15+ Years of

Biosimilar Experience
in Europe
OMNI TROPE ® C A SE S TUDY

NOVEMBER

2022
Introduction
Biosimilar competition can play a crucial role in the overall economic sustainability
of the healthcare system. Biosimilars hold the potential to improve patient access
to biologic therapies, balance spending, and unlock savings for innovation. IQVIA
Institute has previously published reports on biosimilar sustainability (Advancing
Biosimilar Sustainability, 2018, and Spotlight on Biosimilars, 2021).

This new report continues the conversation by assessing the status of biosimilar
use in selected European countries and, in particular, by analyzing the value
provided by the first biosimilar launched in Europe — Omnitrope®. This utilization
of Omnitrope and the savings associated with it are assessed using proprietary
IQVIA data for selected European countries. With more than 15 years since
its approval, Omnitrope’s value to the overall health system is important to
understand and can provide lessons for ensuring that future biosimilars are
optimally utilized.

This report has been developed independently by the Find Out More
IQVIA Institute for Human Data Science, drawing on
If you wish to receive future reports from the IQVIA
IQVIA proprietary data and published literature across
Institute for Human Data Science or join our mailing list,
selected European countries.
visit iqviainstitute.org

Funding for this research and report has been provided

by Sandoz.
MURRAY AITKEN
Executive Director
IQVIA Institute for Human Data Science

©2022 IQVIA and its affiliates. All reproduction rights, quotations, broadcasting, publications reserved. No part of this publication may be reproduced or
transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without
express written consent of IQVIA and the IQVIA Institute.

15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

Table of Contents
Overview 2

Drug expenditure dynamics and biosimilars: Background and situation 4

Omnitrope®: Clinical background 8

Omnitrope®: Utilization and savings 11

France 16
UK 17
Spain 18
Italy 19
Finland 20
Denmark 21
Norway 22
Germany 23

Discussion 24

Notes on sources 30

Appendix 31

Austria 33
Belgium 34
Bulgaria 35
Croatia 36
Czech Republic 37
Estonia 38
Hungary 39
Kazakhstan 40
Lithuania 41
Luxembourg 42
Netherlands 43
Poland 44
Portugal 45
Romania 46
Russia 47
Slovenia 48
Sweden 49
Switzerland 50

References 52

About the authors 54

About the Institute 55

Overview
Healthcare costs have been increasing across Europe Biosimilars are viewed by the European Medicines
and, given the level of therapeutic advances and unmet Agency as interchangeable with the reference medicine,
patient needs, drug expenditure in major European without a patient experiencing any changes in the
countries is expected to rise by $51 billion between 2021 clinical effect.
and 2026, up from $44 billion in the preceding five years.
Omnitrope®, a biosimilar for somatropin, became the
Biologics have comprised a large proportion of overall
first biosimilar available when it was authorized by the
healthcare costs for the past 10 years, accounting for
European Medicines Agency in 2006. Over the past 15+
34% of drug spending in Europe at list prices, for a total
years, several studies have been conducted that show it
of $103 billion in 2021 and with a compound annual
to be highly similar to Genotropin, the reference product
growth rate (CAGR) of 10.5% over the last five years.
in pharmacokinetic and pharmacodynamic safety and
These drugs provide important innovation and enhance
efficacy profiles, and comparable in quality, safety,
patient care. Supporting these drugs while overcoming
and efficacy. In these 15+ years, Omnitrope has also
challenges of costs and ensuring economic sustainability
witnessed access and uptake in most European countries
is crucial for human health.
and has a 30% share of overall somatropin usage.
Biosimilars offer a solution to the concerns around However, its uptake trajectory differs from more recent
economic sustainability by providing savings to the biosimilar products which have seen uptake.
healthcare system due to their lower costs and the
Given the potential key role that biosimilars can play
increased competitive pressure on reference medicines.
in the economic sustainability of healthcare systems,
The term biosimilar refers to the successor to a biological
it is important to assess the value provided by them.
medicine, also known as the “reference medicine,”
The 15+ years of availability of Omnitrope, in particular,
for which the patent has expired, and exclusivity has
provides a longtime horizon to understand its impact.
been lost. Biosimilars match their respective reference
medicine in terms of quality, safety, and efficacy. Based on analysis of IQVIA MIDAS data, the entry of
Omnitrope (somatropin) has led to more than $1.9 billion
in savings at a list price level across selected European
countries between 2006 and 2021. These savings are

Biosimilars offer a solution to driven by its reduced cost and the increased competitive
pressure on reference medicines.
the concerns around economic
sustainability by providing The level of savings varies across countries, considering
biosimilar uptake, competitive response and regulations
savings to the healthcare system
are different. For example, France witnessed savings
due to their lower costs and the of $670 million, the UK saw savings of $287 million,
increased competitive pressure on and Spain realized savings of $230 million since
biosimilar entry.
reference medicines.

2 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

Biosimilars can also provide value to the healthcare
system through these savings, as they can be used to
broaden access to existing biologics and to fund novel
treatments. In the case of Omnitrope, the overall use of
the somatropin molecule doubled between 2006 and
2021 while costs increased by only 34% in the same
period. On the whole, Omnitrope has provided over
324,000 patient years of treatment since its approval
(up to 2021).
With over 120 biologics losing their exclusivity between
now and 2030, the potential demand for biosimilars
due to these losses of exclusivity is likely to be
around $9 billion. It is crucial that the use of existing
biosimilars as well as those to come are optimized to
ensure a sustainable healthcare system where costs
are manageable, existing medicines have appropriate
Bit volorentis rero bernati occust
access and innovative medicines can be funded and
excea
provided pra doluptatur alita quiam
to patients.

et es volectorere vel idus rem sit

With the annual cost of drugs that treat rare metabolic/
endocrine diseases increasing by ~$2 billion (57%) over ex eturiati berum atiis expero
the past decade for the European countries in-scope, expe pro quunt moluptat qui
the savings provided by biosimilars such as Omnitrope
que none cuscien ihilia aut quam
are critical for the sustainability of the healthcare
system. The variability in the uptake of the lowest cost faccae duciaecae dollut rem.
somatropin product across countries and the relatively
lower uptake of Omnitrope compared to other biosimilars
suggests that there is additional potential for savings.

It is crucial that the use of existing biosimilars as well as those to

come are optimized to ensure a sustainable healthcare system where
costs are manageable, existing medicines have appropriate access
and innovative medicines can be funded and provided to patients.

iqviainstitute.org | 3
Drug expenditure dynamics and biosimilars:
Background and situation
+ Healthcare costs have been rising across Europe, Enhancing the economic sustainability of healthcare
with drug expenditure in major European countries systems while ensuring access to innovative treatments
expected to rise by $51 billion over the next five in an optimal manner poses a challenge for governments
years due to therapeutic advances and unmet across Europe.1 Factors such as aging populations,
needs, up from $44 billion in the past five years. growing disease burden, and growing number of costly
innovative medicines that provide important value are
+ Biologics have comprised a large proportion of
overall healthcare costs for the past 10 years, increasing the pressure on healthcare budgets. Annual

accounting for 34% of drug spending in Europe at growth in per capita health expenditure in Europe in
list prices, for a total of $103 billion in 2021 and with real terms has been on the rise in the past few years, as
a compound annual growth rate (CAGR) of 10.5% shown in Exhibit 1.2
over the last five years.
Additionally, drug expenditure in major European
+ These drugs provide important innovation and countries is expected to rise by $51 billion over the next
enhance patient care. Supporting these drugs five years, up from $44 billion in the past five years
while overcoming challenges of costs and ensuring (Exhibit 2). The most important drivers of the increase in
economic sustainability is crucial for human health. expenditure between 2016 and 2021 were new brands

+ Biosimilars offer a solution to the concerns (i.e., new medicines) and this trend is likely to continue in

around economic sustainability by providing the next five years due to high unmet need and level of
savings to the healthcare system due to their lower innovation. Negative effects of the pandemic, including
costs and the increased competitive pressure on costs of COVID-19 prevention, will continue to impact
reference medicines. reimbursement decisions and marketing operations.4

Exhibit 1: EU healthcare expenditure per inhabitant (EUR), 2012 and 20193

9,000
8,000
7,000
6,000
5,000
4,000
3,000
2,000
1,000
0
EU1

Romania
Estonia
Lithuania
Latvia2
Bulgaria
Czechia2
Croatia2
Poland2
Germany
Portugal
Slovenia3
Hungary
Malta3,4
Austria
Belgium
Cyprus
Spain
Ireland
Luxembourg
Slovakia5
Netherlands
Denmark
Finalnd5
France
Italy
Sweden
Greece

Iceland
Switzerland
Poland2
Norway

Bosnia & Heizeg.2

2012 2019

Source: Eurostat Statistics Explained. Healthcare expenditure statistics. Accessed Oct 2022. Available from:
https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Healthcare_expenditure_statistics
Notes: 12012 not available, 2019 calculated with 2018 Malta data; 22013 instead of 2012; 32014 instead of 2012; 42018 instead of 2019; 5Break in series.

4 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

Exhibit 2: Pharmaceutical spending in Europe through 2026
Forecast

56
15 1 261
13

-33
47 1 210
14

-11
-7

166 380

2016 New LOE Existing Generics Others 2021 New LOE Existing Generics Others 2026
Spending brands brands spending brands brands spending

Source: IQVIA Market Prognosis, Sep 2021; IQVIA Institute, Nov 2021.

Biologics represent an increasingly significant last five years. In contrast, the total market — comprising
proportion of pharmaceutical expenditure due to their of small molecules, biologics, and biosimilars —
efficacy in treating complex conditions and their cost recorded a CAGR of only 5.1% in the same period (Exhibit
of development. Biologics have comprised a large
5
3 and 4). These drugs provide important innovation and
proportion of overall healthcare costs for the past enhance patient care. Supporting these drugs while
10 years, accounting for 34% of drug spending in Europe overcoming challenges of costs and ensuring economic
at list prices, for a total of $103 billion in 2021 and with a sustainability is crucial for human health.
compound annual growth rate (CAGR) of 10.5% over the

Exhibit 3: Biologics are a growing proportion of overall drug spending in Europe

EU spending (%) EU growth (YoY, %)

100% 12
Biologics,
Year-over year (YoY) sprending growth (%)

90% 11
CAGR (2016–2020):
Share of total EU Rx market (%)

10 10.5%
80%
9
70%
66 8
60% 77 7 Total EU market,
CAGR (2016–2020):
50% 6 5.1%
40% 5
4
30%
3 Small molecules,
20% CAGR (2016–2020):
2
34% 2.7%
10% 23% 1
0% 0
2010 2021 2016 2017 2018 2019 2020

Biologics Non-biologics

Source: IQVIA MIDAS (Q2 2021), Rx only; Biologic molecules exclude ATC-V (vaccines and various).

iqviainstitute.org | 5
 Exhibit 4: Spending in Europe on biologics has grown 10.5% annually over the last five years, reaching more
than $103Bn in 2021
Volume shares in Europe by competitor, 2021
120

100
Sales constant US$ Bn

80

60

40

20

0
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

The loss of exclusivity on biologic products allows for the
entry of biosimilars. “A biosimilar is a biological medicine
highly similar to another already approved biological
medicine (the ‘reference medicine’).” Biosimilars provide5
an opportunity to mitigate some of the concerns around
economic sustainability due to their lower costs and the
increased competitive pressure that they provide.
Biosimilars provide an
opportunity to mitigate
The European biosimilar market is the world’s largest,
with the first biosimilar (Omnitrope) launched in 2006.
The extent of biosimilar competition to biologics in the
European Union has seen an acceleration in the recent
past, with EMA biosimilar approvals increasing in 2017
and 2018.4,7 Since Omnitrope was first authorized in
2006, nearly 90 applications have been approved in
Europe.8 Fifteen years after Omnitrope’s approval in the
EU (i.e., 2006 to 2021), biosimilars had recorded a total
of more than 2 billion patient treatment days of clinical
experience, leading to growing trust in these medicines.1
In the past decade, the cumulative number of patient
treatment days for EU-approved biosimilars have
doubled about every 1.5 years.9 Total days of biosimilar

some of the concerns around therapy in Europe have risen from 11% of the accessible
market in 2016 to 27% in 2021 (Exhibit 5).
pharmaceutical expenditure
Biosimilars can be more affordable and may improve
due to their lower costs and the
patient access to life-altering biologics.1 European
increased competitive pressure governments are aiming to eliminate ineffective or
that they provide. wasteful spending on health and maximize value for
money, particularly with COVID-19 placing an extra
burden on health systems at a time of economic
uncertainty.10 To ensure efficient utilization of resources,

6 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

 Exhibit 5: Biosimilar days of therapy have grown in Europe, representing 27% of the accessible market in 2021,
up from 11% in 2016

European biosimilar accessible market defined daily doses and 2021 biosimilar share
3.0

2.5

27%
2.0

2021 =
DDDs Bn

1.5 2.8Bn DDDs

1.0 73%

0.5

Biosimilars
0
Bisimilar accessible market
2005 2007 2009 2011 2013 2015 2017 2019 2021

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Biosimilar accessible market consists of non-biosimilar products for which a biosimilar has launched in that country. Biosimilar launch date is
determined by the earliest biosimilar to launch for a molecule in each country analyzed.

policies are increasingly being considered and adopted
to incentivize the use of biosimilars over originator
biologics.11 Additionally, in September 2022, the EMA and
the Heads of Medicines Agencies (HMA) issued a joint
statement confirming that biosimilar medicines approved
in the EU are interchangeable with their reference
medicine or with an equivalent biosimilar, further
strengthening the confidence in biosimilar usage.12
With more than fifteen years since Omnitrope’s approval,
it is important to analyze the value provided by the entry
of this biosimilar on the overall healthcare system by
assessing the sales and volume data across Europe. Until
now, there have been a few studies that have looked at
savings provided by biosimilars in individual countries;
however, a broad assessment across countries in Europe
has not been done.

iqviainstitute.org | 7
Omnitrope®: Clinical Background
+ Omnitrope®, a biosimilar for somatropin, became
the first biosimilar available when it was authorized
by the European Medicines Agency in 2006
+ Over the past 15+ years, several studies have
been conducted that show Omnitrope to be highly
similar to Genotropin, the reference product in
pharmacokinetic and pharmacodynamic safety and
efficacy profiles, and comparable in quality, safety
and efficacy
Omnitrope became the world’s first biosimilar when
authorized by the European Medicines Agency on April
12, 2006.13 Omnitrope was also the first biosimilar to
be approved in Japan, Canada and Taiwan and was
approved as the first follow-on version of somatropin in
the United States and Australia.14 As of 2017, Omnitrope
was available in more than 50 countries, and more
than 40,000 patients had been treated with biosimilar
recombinant human growth hormone (rhGH), amounting
to nearly 107 million patient-days of experience.15
A comparative analysis of Phase III data concluded
that switching from Genotropin to Omnitrope solution
has no impact on efficacy or safety in children with
growth hormone deficiency, and that the various rhGH
preparations were well tolerated.18
Post-approval experience
Several published studies examined the safety and
efficacy of Omnitrope after the product had been on
the market for more than 10 years, including data from
the Patients Treated with Omnitrope (PATRO) Children
and PATRO Adults studies (Exhibit 1). These studies
consistently show that Omnitrope was well tolerated
and effective across pediatric and adult indications in
real-world clinical practice, consistent with the results
of controlled clinical trials.19–24 A voluntary category
three post-authorization study (PASS) of the safety and
effectiveness data in pediatric patients treated with
Omnitrope in various indications found that therapy was
effective, and the intensity of most AEs was mild
or moderate.25

Clinical development In addition, a study found that the growth trajectories of

A broad set of comparative studies exist for Omnitrope, rhGH-treated patients were not negatively impacted by
which include head-to-head studies showing it to be switching to Omnitrope from other rhGH therapies. 26
highly similar to Genotropin, the reference product in
pharmacokinetic and pharmacodynamic safety and
efficacy profiles, and comparable in quality, safety
and efficacy.15,17

NOTES

Omnitrope® (recombinant human growth hormone, rhGH) solution is a non-glycosylated protein consisting of
191 amino acid residues and accounting for a total molecular weight of approximately 22,125 daltons, with a
biological activity of 3.0 IU/mg and an isoelectric point of 5.1. The protein is produced by fermentation in an
Escherichia coli host strain and subsequently isolated and purified by chromatographic means.16

8 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

Exhibit 6: Findings of selected post-approval studies of Omnitrope

POST-APPROVAL
STUDY FINDINGS
STUDY AUTHORS

A study reporting the first data from 1,837 children enrolled in the Patients Treated with Omnitrope
(PATRO) Children study, an ongoing, international, longitudinal, non-interventional study in children
who require rhGH treatment study that was set up in 2006 as an element of the post-approval
PFÄFFLE ET AL, pharmacovigilance requirements and risk management plan. Data from 10 European countries up
201323 to September 2012 indicated that the efficacy and safety profile of Omnitrope were as expected.
The authors noted that, “To date, efficacy data are reassuring and consistent with previous studies.
In addition, there have been no confirmed cases of diabetes occurring under Omnitrope treatment,
no reports of malignancy and no safety issues in Prader–Willi syndrome patients.”

This study describes a retrospective study of 103 patients between January 1, 2006 and July 31,
RASHID ET AL, 2011, finding that the growth trajectories of rhGH-treated patients were not negatively impacted by
2014 27 switching to Omnitrope from other rhGH therapies, and that growth rates remained as expected prior
to the switch.

An interim analysis of PATRO Children study data from Italy covered 186 patients enrolled to
IUGHETTI ET AL, August 2015, concluding that Omnitrope appears to be well tolerated and effective for the
201622 treatment of a wide range of pediatric indications, which is consistent with the outcomes from
controlled clinical trials.

This study of 10 years’ clinical experience with a focus on safety data notes that there is a substantial
data set to fully understand the safety profile of biosimilar rhGH, including almost 107 million
patient days (292,790 patient-years) experience as of June 2016. Based on these data, no unexpected
or unique adverse events related to biosimilar rhGH treatment have been seen. The authors
BORRÁS PÉREZ ET conclude that there is no increased risk of cancer, adverse glucose homeostasis, or immunogenic
AL, 2017)27 response with biosimilar rhGH compared with the reference medicine and other rhGH products.
Immunogenicity is also judged to be similar to the reference and other rhGH products. The authors
write, “Physicians should be reassured that rhGH products have a good safety record when used for
approved indications and at recommended doses, and that the safety profile of biosimilar rhGH is in
keeping with that of other rhGH products.”

This study of 10 years’ clinical experience with a focus on efficacy data “affirms the clinical efficacy
LÓPEZ-SIGUERO ET and effectiveness of biosimilar rhGH across all approved indications…biosimilar rhGH is an effective
AL, 2017 25
treatment option for children who require therapy with rhGH.”

This paper describes more than 10 years’ experience from the PATRO Children study. The study had
PFÄFFLE ET AL, enrolled 6,009 patients at 298 centers in 14 countries as of November 2017. The paper concludes that
202023
biosimilar rhGH is well tolerated and effective in real-world clinical practice.

continued on page 10

iqviainstitute.org | 9
Exhibit 6: Findings of selected post-approval studies of Omnitrope continued

POST-APPROVAL
STUDY FINDINGS
STUDY AUTHORS

Experience from the prospective PATRO children and adult studies over 10 years to January 2019 in
LUNDBERG ET AL, Sweden has also been reported. Based on data from 136 children and 293 adults, the study authors
202020 write that the 10-year data suggest that biosimilar rhGH is well tolerated across pediatric and adult
indications.

A ‘snapshot analysis’ of data from 88 patients in the PATRO Adults study at eight sites in Italy
AROSIO ET AL, between September 2007 and August 2017 also concluded that these confirmed the long-term safety
202128
and effectiveness of Omnitrope in adults with GHD.

A study of safety and effectiveness of replacement with biosimilar growth hormone in 1,447 patients
HÖYBYE ET AL, in the PATRO Adults study at 82 centers in nine European countries concluded that Omnitrope is
202124 not associated with any unexpected safety signals and is effective in adults with growth hormone
deficiency treated in real-world clinical practice.

Sandoz carried out an international, non-interventional, non-controlled, longitudinal, open and

multicenter, voluntary category three post-authorization study (PASS) designed to record the safety
and effectiveness data of 7,359 pediatric patients treated with Omnitrope in various indications.
EMA SUMMARY The study took place in 2006-20 in 11 European countries, North America, Canada, Australia, and
OF PRODUCT Taiwan. The EMA website notes that the majority of AEs assessed as related to Omnitrope treatment
CHARACTERISTICS
were expected based on the summary of product characteristics (SmPC) and as known for growth
FOR OMNITROPE
hormones; the intensity of most AEs was mild or moderate. The effectiveness results, assessed in
(2021) 17
6,589 pediatric patients, show that Omnitrope treatment was effective and resulted in a substantial
catch-up growth which are consistent with those reported in observational studies of other
approved rhGH medicines.

A review of efficacy data for Omnitrope (López-Siguero
et al, 2017) states that “the decade of experience
25
with biosimilar rhGH since it was approved in Europe
confirms the scientific validity of the biosimilar pathway
and the approval process. Concerns about clinical effect
in extrapolated indications, and also about the impact
of changing from other rhGH preparations, have been
alleviated.”
Another post-approval study (Borrás Pérez et al, 2017)
notes that with its lack of unexpected or unique safety
concerns, this study supports the use of extrapolation as
part of the EMA framework for approval of biosimilars.
“Physicians should be reassured that rhGH products
have a good safety record when used for approved
indications and at recommended doses, and that the
safety profile of biosimilar rhGH is in keeping with that of
other rhGH products,” the authors conclude.
The long-term experience with Omnitrope from a clinical
perspective is well understood; however, analysis of its
use and the associated savings over the past 15+ years
28
is limited. The next chapter utilizes proprietary IQVIA
data to assess the utilization and savings associated with
Omnitrope.

10 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

Omnitrope®: Utilization and Savings
+ The entry of Omnitrope® (somatropin), the first
biosimilar approved by EMA in 2006, has led to
more than $1.9 billion in savings at a list price
level across selected European countries between
2006 and 2021 (approximately 14% of the overall
somatropin spending in the same time period) due
to its reduced cost and competitive pressure on
reference medicines.
+ This level of savings varies across countries as
biosimilar uptake, competitive response and
regulations are different. For example, France
witnessed savings of $670 million, the UK saw
savings of $287 million and Spain saw savings
of $230 million since biosimilar entry.
+ Overall somatropin usage increased by 101%
between 2006 and 2021, while costs increased
by 34%.
+ Omnitrope provided more than 324,000 patient
years of treatment since its approval (up to 2021).
IQVIA’s proprietary MIDAS dataset was utilized to
analyze the value provided by the entry of Omnitrope.
The objective of the analysis was to provide a broad
overview of the evolution of the somatropin market after
the entry of a biosimilar. This involves assessing the
total use of Omnitrope (and somatropin products) and
the savings due to the entry of Omnitrope (from 2006 to
2021) across several European countries (See appendix
for list of countries included in the analysis; details on
the dataset, key variables, analytical approach, and
reasons for exclusion of certain countries can also be
found in the appendix).
Omnitrope has been approved and available for over
15 years and has generated a large body of evidence
to support its safety and efficacy. In these 15+ years,
Omnitrope has also witnessed access and uptake in
most European countries; however, its uptake trajectory
differs from more recent biosimilar products with market
share at around 30%, while other recent ones have seen
greater uptake of the share. (Exhibit 7b).

Exhibit 7a: Biosimilar uptake by volume varies across the therapy areas

Volume shares in Europe by competitor, 2021

100%
Originator
90%
80% Biosimilar 1

70% Biosimilar 2
60%
Biosimilar 3
50%
40% Biosimilar 4

30% Biosimilar 5
20%
Biosimilar 6
10%
0% Biosimilar 7
)

4)

4)

7)

7)

7)

8)

9)

0)

0)
06

07

13

16

17
00

01

ce 01

01

01

01

01

01

02

02
0

20

20
(2

(2

(2

(2

(2

(2

(2

(2

(2

(2

(2

(2

(2
t(

(
n

fa

tim

ab

fa

ab

ab

im

rt
p
et gin

id
pr

a
pi

pa
al

al
m

um

im

m
st

at
ro

as

lis

as
tin

in

er

ra
ar
xi

zu

zu
ar
ux
at

gr

im
p

lin
fli

an

ilg
gl

tu

ci
oe

lin
rip
m

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rit
fil

in

al

va
su

gf
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su
ep

te
ad
lli

be
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pe
in

tr

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fo

s
in

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Calculations are based on defined daily dose shares where each medicine is normalized to a standardized dose per day to adjust for formulation
differences between originators and biosimilars. Somatropin has six originator/different generations of somatropin products. Year of biosimilar entry is
based on earliest biosimilar launch across European countries analyzed.

iqviainstitute.org | 11
Exhibit 7b: While most recent biosimilars have more than 60% uptake within 5 years, somatropin remains at
30% 15+ years after biosimilar entry
Biosimilar uptake rates in Europe quarters after launch, defined daily doses
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
0 1 2 3 4 5 6 7
Years after biosimilar launch
Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.
There can be several reasons for this difference in uptake
(from strong originator preference, lower understanding
of biosimilars as it was the first one to be launched, need
to build trust as it was the first biosimilar, rebates etc.),
which need to be well understood to ensure that optimal
usage and savings are achieved.
Across Europe, the timing of Omnitrope’s launch varied,
with some countries seeing sales in 2006 (such as France
and Germany) while in other countries, the first sales
took place later. Exhibit 8 shows the overall impact that
Omnitrope’s entry had across all the countries in-scope,
while Exhibits 9-16 showcase the impact for some of the
countries in-scope based on the earlier mentioned analysis.
There has been a gradual increase in the Omnitrope
share of the somatropin market in terms of volume as
more countries have provided access to the biosimilar
and there has been greater acceptance of it across all
countries (Exhibit 8). The percentage share increased
from 13% in 2012 to 30% in 2022.
Overall, there has been an increase of 101% in annual
somatropin volume use since 2006 while the overall
sales have only increased by 34%. Several factors may
12 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study
infliximab
bevacizumab
rituximab
pegfilgrastim
adalimumab
etanercept
trastuzumab
somatropin
8 9 10 11 12 13 14 15
be behind this increase in volume, including overall
population growth, improved access to healthcare, and
improved access to the molecule due to the biosimilar,
which creates competitive pressure on the market and
leads to lower costs. Across the countries, Omnitrope
has had greater than 300,000 patient years of usage over
the 15 years, with the highest use taking place in France,
Spain, Germany, and Poland.
The total cumulative savings associated with Omnitrope
across all countries since 2006 is estimated to be $1.9 billion
at a list price level (approximately 14% of the overall
somatropin spending in the same period) with the highest
savings taking place in France, Spain, the UK, and Italy.
These savings are driven by a 33% reduction in the cost per
daily defined dose for the somatropin molecule (averaged
across all products) between 2006 and 2021. These savings
are important for overall healthcare sustainability. To put
the situation in context, these savings represent around
10% of the total savings from all biosimilars (See Appendix
for IQVIA estimate of total savings across all biosimilars).
Additionally, total biologics spending in Europe (Selected
countries - see appendix) in 2021 was around $100 billion
and the total spent on cancer drugs in 2021 was $33 billion.
Exhibit 8a: Somatropin sales across Europe have grown 34% since Omnitrope was first launched in 2006

Annual somatropin sales constant US$ Mn, 2005–2021

1,000

900

800

700
Constant US$ Mn

600 +34%
increase since
500 biosimilar
entry in 2006
400

300

200

100

0
2005 2007 2009 2011 2013 2015 2017 2019 2021

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Europe refers to select countries where data was available. See Appendix for details.

Exhibit 8b: Somatropin usage has increased 101% across Europe since Omnitrope was first launched in 2006

Annual somatropin defined daily doses (Mn), 2005–2021

70

60

50

40

30

20 +101%
increase since
biosimilar
10 entry in 2006

0
2005 2007 2009 2011 2013 2015 2017 2019 2021

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here. Europe refers to select countries
where data was available. See Appendix for details.

iqviainstitute.org | 13
Exhibit 8c: Omnitrope has provided more than 324K patient years of treatment in Europe since it first launched
in 2006

Cumulative Omnitrope patient years, 2005–2021

350,000

300,000

250,000

200,000 324K
patient
150,000 years

100,000

50,000

0
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Europe refers to select countries where data was available. See Appendix for details.

Exhibit 8d: European countries have saved (at a list price level) nearly $2Bn on somatropin spending since
biosimilar entry in 2006

Cumulative savings after biosimilar entry, 2005–2021

0

-200

-400

-600

-800
$1.9Bn
in savings
following
-1,000 biosimilar
entry in
-1,400 2006

-1,600

-1,800

-2,000
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Europe refers to select countries where data was available. See Appendix for details.

14 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

Exhibit 8e: Cost per day of therapy (at list price level) for somatropin has declined across Europe since biosimilar
entry in markets beginning in 2006

Somatropin cost per Defined Daily Dose (DDD) in Europe, 2005–2021 (average cost across all somatropin products)
$25
$23.24

$20

Earliest
biosimilar
$15 entry $15.96

$10

$5

$0
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Further reductions may be taking place due to discounts and rebates. Europe refers to select countries where data was available. See Appendix for details.

Exhibit 8f: Omnitrope now accounts for 30% of somatropin usage in Europe, up from 13% a decade ago

Omnitrope share of somatropin defined daily doses, 2005–2021

100%

90%

80%

70%

60%

50%
30%
40% of somatropin
use is
30% Omnitrope
20%

10%

0%
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Europe refers to select countries where data was available. See Appendix for details.

Further details on the use and savings associated with Omnitrope at a country level can be found in Exhibits 9–16.

iqviainstitute.org | 15
 USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

France has witnessed a substantial increase in somatropin usage,

while overall spending has not increased as much
France, 2006–2021
France has witnessed a substantial increase of 84% in somatropin usage between 2006 and 2021, while the costs have
only increased by 29%. The total savings associated with Omnitrope® between 2006 and 2021 at a list price level are
$670 million.

Annual
Annualsomatropin
somatropinsales
sales
Exhibit 9A: Annual somatropin sales Exhibit 9B: Annual somatropin DDDs
250
250 12
12

200
200 10
10
+29%
+29% +82%
+82%
US$ Mn
Mn

88
Constant US$

150
150 increase
increase increase
increase

Millions
Millions
since
since since
since
66
Constant

biosimilar
biosimilar biosimilar
biosimilar
100
100 entry
entryinin entry
entryinin
2007
2007 44 2007
2007
50
50
22

00 00
2006
2006 2011
2011 2016
2016 2021
2021 2006
2006 2011
2011 2016
2016 2021
2021

Exhibit 9C: Cumulative Omnitrope patient years Exhibit 9D: Omnitrope share of somatropin DDDs

50,000
50,000 20%
20%

40,000
40,000
15%
15%
18%
18%
30,000
30,000 47,933
47,933 ofof
somatropin
somatropin
patient
patient
years
years 10%
10% use
useisis
20,000
20,000 Omnitrope
Omnitrope

5%
5%
10,000
10,000

00 0%
0%
2006
2006 2011
2011 2016
2016 2021
2021 2006
2006 2011
2011 2016
2016 2021
2021

Exhibit 9E: Competitive pressure after biosimilar entry and reduced prices has led to savings in France
Annual somatropin savings by product in France, constant US$ Mn, 2007-2021

20 100%
90%
$670Mn
0 in savings following
80% biosimilar entry in 2007
-20
Constant US$ Mn

70% Zomacton
-40 60% Saizen
-60 50% Omnitrope
-80 40%
Nutropinaq
30%
-100 Norditropin
20%
-120 Humatrope
10%
Genotropin
-140 0%
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 Omnitrope share

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

16 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

 USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Usage of somatropin has risen by ~140% since the entry of the

biosimilar in the UK in 2006
UK, 2006–2021
Usage of somatropin has risen by 140% in the United Kingdom since the launch of Omnitrope®, while costs have risen
by 58%. The overall savings associated with the launch of Omnitrope between 2006 and 2021 at a list price level are
$287 million, largely driven by competitive pressure on reference medicines due to biosimilar entry.

Annual
Annualsomatropin
somatropinsales
sales
Exhibit 10A: Annual somatropin sales Exhibit 10B: Annual somatropin DDDs
80
80 66
70
70
55
60
60
+58%
+58% +140%
+140%
US$ Mn
Mn

44
Constant US$

50
50 increase
increase increase
increase

Millions
Millions
since
since since
since
40
40 33
Constant

biosimilar
biosimilar biosimilar
biosimilar
30
30 entry
entryinin entry
entryinin
2007
2007 22 2007
2007
20
20
11
10
10
00 00
2006
2006 2011
2011 2016
2016 2021
2021 2006
2006 2011
2011 2016
2016 2021
2021

Exhibit 10C: Cumulative Omnitrope patient years Exhibit 10D: Omnitrope share of somatropin DDDs

21,000
21,000 40%
40%

18,000
18,000 35%
35%

15,000
15,000
30%
30%
34%
34%
12,000
12,000
17,631
17,631 25%
25% ofof
somatropin
somatropin
patient
patient
years
years 20%
20% use
useisis
9,000
9,000 Omnitrope
Omnitrope
15%
15%
6,000
6,000 10%
10%
3,000
3,000 5%
5%
00 0%
0%
2006
2006 2011
2011 2016
2016 2021
2021 2006
2006 2011
2011 2016
2016 2021
2021

Exhibit 10E: Competitive pressure after biosimilar entry, reduced prices and increasing use of Omnitrope has led
to savings Annual somatropin savings by product in UK, constant US$ Mn, 2007-2021
5 100%
90%
$287Mn
0 in savings following
80% biosimilar entry in 2007
-5
Constant US$ Mn

70% Zomacton
-10
60% Saizen
-15 50% Omnitrope
-20 40%
Nutropinaq
30%
-25 Norditropin
20%
-30 Humatrope
10%
Genotropin
-35 0%
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 Omnitrope share

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

iqviainstitute.org | 17
 USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Spain has seen >100% increase in use of somatropin since 2006

Spain, 2006–2021

Spain has seen a doubling of somatropin usage, while costs have increased by 63%. The overall savings associated with
the launch of Omnitrope® between 2006 and 2021 at a list price level are $230 million, largely driven by competitive
pressure on reference medicines due to biosimilar entry.

Annual
Annualsomatropin
somatropinsales
sales
Exhibit 11A: Annual somatropin sales Exhibit 11B: Annual somatropin DDDs
140
140 10
10
120
120
88
+63%
+63% +101%
+101%
US$ Mn
Mn

100
100
Constant US$

increase
increase increase
increase
80
80 66

Millions
Millions
since
since since
since
Constant

biosimilar
biosimilar biosimilar
biosimilar
60
60 entry
entryinin entry
entryinin
44
2007
2007 2007
2007
40
40
22
20
20

00 00
2006
2006 2011
2011 2016
2016 2021
2021 2006
2006 2011
2011 2016
2016 2021
2021

Exhibit 11C: Cumulative Omnitrope patient years Exhibit 11D: Omnitrope share of somatropin DDDs

50,000
50,000 30%
30%

25%
25%
40,000
40,000
28%
28%
30,000
30,000 40,071
40,071 20%
20% ofof
somatropin
somatropin
patient
patient
years
years 15%
15% use
useisis
20,000
20,000 Omnitrope
Omnitrope
10%
10%
10,000
10,000 5%
5%

00 0%
0%
2006
2006 2011
2011 2016
2016 2021
2021 2006
2006 2011
2011 2016
2016 2021
2021

Exhibit 11E: Competitive pressure after biosimilar entry and reduced prices has led to savings in Spain
Annual somatropin savings by product in Spain, constant US$ Mn, 2007-2021
5 100% $230Mn
in savings following
0 90% biosimilar entry in 2007
-5 80%
Constant US$ Mn

Zomacton
-10 70%
Saizen
60%
-15
50% Omnitrope
-20
40% Nutropinaq
-25 Norditropin
30%
-30 20% Humatrope
-35 10% Genotropin
-40 0% Omnitrope share
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

18 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

 USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Italy has witnessed an increase in somatropin usage, while overall

spending has not increased as much
Italy, 2006-2021
Italy has also seen an increase in somatropin usage at a faster rate than the increase in costs. The overall savings
associated with the launch of Omnitrope® between 2006 and 2021 at a list price level are $166 million, with use of
Omnitrope responsible for 52% of the savings and the rest driven by competitive pressure due to biosimilar entry.

Annual
Annualsomatropin
somatropinsales
sales
Exhibit 12A: Annual somatropin sales Exhibit 12B: Annual somatropin DDDs
120
120 77
100
100 66

+29%
+29% +57%
+57%
US$ Mn
Mn

80
80 55
Constant US$

increase
increase increase
increase

Millions
Millions
since
since 44 since
since
60
60
Constant

biosimilar
biosimilar biosimilar
biosimilar
entry
entryinin 33 entry
entryinin
40
40 2007
2007 2007
2007
22
20
20 11

00 00
2006
2006 2011
2011 2016
2016 2021
2021 2006
2006 2011
2011 2016
2016 2021
2021

Exhibit 12C: Cumulative Omnitrope patient years Exhibit 12D: Omnitrope share of somatropin DDDs
35,000
35,000
30%
30%
30,000
30,000
25%
25%
25,000
25,000 25%
25%
20,000
20,000
31,950
31,950 20%
20% ofof
somatropin
somatropin
patient
patient
years
years 15%
15% use
useisis
15,000
15,000 Omnitrope
Omnitrope
10%
10%
10,000
10,000

5,000
5,000 5%
5%

00 0%
0%
2006
2006 2011
2011 2016
2016 2021
2021 2006
2006 2011
2011 2016
2016 2021
2021

Exhibit 12E: Omnitrope’s use was responsible for 52% of the savings on somatropin, with competitive pressure
a factor in other savings other savings Annual somatropin savings by product in Italy, constant US$ Mn, 2007-2021

10 100% $166Mn
in savings following
5 90% biosimilar entry in 2007
80%
0
Constant US$ Mn

Zomacton
70%
-5 Saizen
60%
-10 50% Omnitrope
40% Nutropinaq
-15
30% Norditropin
-20
20% Humatrope
-25 10% Genotropin
-30 0% Omnitrope share
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

iqviainstitute.org | 19
 USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Somatropin usage has doubled in Finland since Omnitrope®

launched in 2007, while spending has not increased as much
Finland, 2006-2021
Usage of somatropin has doubled in Finland since the launch of Omnitrope®, while costs have risen by 19%. The overall
savings associated with the launch of Omnitrope® between 2006 and 2021 at a list price level are $41 million, largely
driven by competitive pressure on reference medicines due to biosimilar entry.

Annual
Annualsomatropin
somatropinsales
sales
Exhibit 13A: Annual somatropin sales Exhibit 13B: Annual somatropin DDDs
10
10
800
800

88
+19%
+19% +100%
+100%
US$ Mn
Mn

600
600
Constant US$

66 increase
increase increase
increase

Millions
Millions
since
since since
since
400
400
Constant

biosimilar
biosimilar biosimilar
biosimilar
44 entry
entryinin entry
entryinin
2007
2007 2007
2007
200
200
22

00 00
2006
2006 2011
2011 2016
2016 2021
2021 2006
2006 2011
2011 2016
2016 2021
2021

Exhibit 13C: Cumulative Omnitrope patient years Exhibit 13D: Omnitrope share of somatropin DDDs

2,500
2,500 20%
20%

2,000
2,000
15%
15%
15%
15%
1,500
1,500 2,002
2,002 ofof
somatropin
somatropin
patient
patient
years
years 10%
10% use
useisis
1,000
1,000 Omnitrope
Omnitrope

5%
5%
500
500

00 0%
0%
2006
2006 2011
2011 2016
2016 2021
2021 2006
2006 2011
2011 2016
2016 2021
2021

Exhibit 13E: In Finland, savings have been driven by lower reference medicine prices due to competitive pressure
after biosimilar entry Annual somatropin savings by product in Finland, constant US$ Mn, 2007-2021
1
0
100%
90%
$41Mn
in savings following
-1 80% biosimilar entry in 2007
Constant US$ Mn

-2 70% Zomacton
60% Saizen
-3
50% Omnitrope
-4
40%
-5 Nutropinaq
30%
-6 Norditropin
20%
Humatrope
-7 10%
Genotropin
-8 0%
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 Omnitrope share

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

20 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

 USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Omnitrope® represents more than two-thirds of somatropin use

in Denmark
Denmark, 2006–2021
Denmark has seen $28 million in savings at a list price level between 2006 and 2021 due to competitive pressure after
biosimilar entry and increasing use of Omnitrope®. The rate of increase in somatropin usage is slightly higher than the
rate of increase in costs.

Annual
Annualsomatropin
somatropinsales
sales
Exhibit 14A: Annual somatropin sales Exhibit 14B: Annual somatropin DDDs
25
25
1.0
1.0

20
20
0.8
0.8
+32%
+32% +40%
+40%
US$ Mn
Constant US$ Mn

15
15 increase
increase increase
increase
0.6
0.6

Millions
Millions
since
since since
since
Constant

biosimilar
biosimilar biosimilar
biosimilar
10
10 entry
entryinin 0.4
0.4 entry
entryinin
2007
2007 2007
2007
55 0.2
0.2

00 0.0
0.0
2006
2006 2011
2011 2016
2016 2021
2021 2006
2006 2011
2011 2016
2016 2021
2021

Exhibit 14C: Cumulative Omnitrope patient years Exhibit 14D: Omnitrope share of somatropin DDDs

15,000
15,000 100%
100%

12,000
12,000 80%
80%
68%
68%
9,000
9,000 13,360
13,360 60%
60%
ofof
somatropin
somatropin
patient
patient
years
years use
useisis
6,000
6,000 40%
40% Omnitrope
Omnitrope

3,000
3,000 20%
20%

00 0%
0%
2006
2006 2011
2011 2016
2016 2021
2021 2006
2006 2011
2011 2016
2016 2021
2021

Exhibit 14E: Reduction in prices due to competitive pressure after biosimilar entry and increasing use of
Omnitrope has led to savings Annual somatropin savings by product in Denmark, constant US$ Mn, 2007-2021
1 100%
90%
$28Mn
0 in savings following
80% biosimilar entry in 2007
Constant US$ Mn

-1 70% Zomacton
-2 60% Saizen
50% Omnitrope
-3
40%
Nutropinaq
-4 30%
Norditropin
20%
-5 Humatrope
10%
Genotropin
-6 0%
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 Omnitrope share

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

iqviainstitute.org | 21
 USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Omnitrope® has seen >1,000 patient years of use in Norway

Norway, 2009–2021

Norway has seen $28 million in savings at a list price level between 2010 and 2021 due to competitive pressure after
biosimilar entry. The rate of increase in somatropin usage is slightly higher than the rate of increase in costs.

Annual
Annualsomatropin
somatropinsales
sales
Exhibit 15A: Annual somatropin sales Exhibit 15B: Annual somatropin DDDs
18
18 1.2
1.2

15
15 1.0
1.0
+21%
+21% +34%
+34%
US$ Mn
Mn

12
12 0.8
0.8
Constant US$

increase
increase increase
increase

Millions
Millions
since
since since
since
99
Constant

biosimilar
biosimilar 0.6
0.6 biosimilar
biosimilar
entry
entryinin entry
entryinin
66 2010
2010 0.4
0.4 2010
2010

33 0.2
0.2

00 0.0
0.0
2009
2009 2012
2012 2015
2015 2018
2018 2021
2021 2009
2009 2012
2012 2015
2015 2018
2018 2021
2021

Exhibit 15C: Cumulative Omnitrope patient years Exhibit 15D: Omnitrope share of somatropin DDDs
1,200
1,200 15%
15%

1,000
1,000 12%
12%
1%
1%
800
800
1,010
1,010 9%
9% ofof
somatropin
somatropin
patient
patient
600
600 years
years use
useisis
6%
6% Omnitrope
Omnitrope
400
400
3%
3%
200
200

00 0%
0%
2009
2009 2012
2012 2015
2015 2018
2018 2021
2021 2009
2009 2012
2012 2015
2015 2018
2018 2021
2021

Exhibit 15E: Savings in Norway are driven by lower prices due to competitive pressure after biosimilar entry
Annual somatropin savings by product in Norway, constant US$ Mn, 2007–2021

1 100%
90%
$28Mn
0 in savings following
80% biosimilar entry in 2010
Constant US$ Mn

-1
70% Zomacton
-2 60% Saizen
-3 50% Omnitrope
-4 40%
Nutropinaq
30%
-5 Norditropin
20%
-6 Humatrope
10%
Genotropin
-7 0%
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 Omnitrope share

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

22 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

 USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Germany has seen more than 30,000 patient years of usage

of Omnitrope®
Germany, 2005–2021
In Germany, Omnitrope® has contributed $92 million in savings due to its lower costs; however, overall costs have not seen a
reduction as prices (at list price level) for reference products have not changed substantially between 2006 and 2021.

Annual
Annualsomatropin
somatropinsales
sales
Exhibit 16A: Annual somatropin sales Exhibit 16B: Annual somatropin DDDs
300
300 77

250
250 66

+42%
+42% +36%
+36%
US$ Mn
Mn

200
200 55
Constant US$

increase
increase increase
increase

Millions
Millions
since
since 44 since
since
150
150
Constant

biosimilar
biosimilar biosimilar
biosimilar
entry
entryinin 33 entry
entryinin
100
100 2006
2006 2006
2006
22
50
50 11

00 00
2005
2005 2009
2009 2013
2013 2017
2017 2021
2021 2005
2005 2009
2009 2013
2013 2017
2017 2021
2021

Exhibit 16C: Cumulative Omnitrope patient years Exhibit 16D: Omnitrope share of somatropin DDDs
35,000
35,000 30%
30%

30,000
30,000 25%
25%
25,000
25,000 26%
26%
20,000
20,000
31,911
31,911 20%
20%
ofof
somatropin
somatropin
patient
patient
15%
15% use
useisis
years
years
15,000
15,000 Omnitrope
Omnitrope
10%
10%
10,000
10,000

5,000
5,000 5%
5%

00 0%
0%
2005
2005 2009
2009 2013
2013 2017
2017 2021
2021 2005
2005 2009
2009 2013
2013 2017
2017 2021
2021

Exhibit 16E: While overall costs initially increased in Germany due to rise in reference medicine prices,
Omnitrope has contributed $92Mn in savings since 2006 Annual somatropin savings by product in Germany, constant
US$ Mn, 2006-2021 and Omnitrope Market Share
20 100%
90%
15
80%
Constant US$ Mn

10 70% Zomacton
5 60% Saizen
50% Omnitrope
0 40%
Nutropinaq
-5 30%
Norditropin
20%
-10 Humatrope
10%
Genotropin
-15 0%
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 Omnitrope share
Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.
Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here. Germany saw the price of
non-Omnitrope somatropin products (at a list price level) increase around the time of Omnitrope launch. These prices started to decrease in subsequent years
but not as much to offset the initial rise, therefore, savings across all somatropin products was not achieved

iqviainstitute.org | 23
Discussion
+ Biosimilars can provide value to the healthcare
system through savings, which can be used
to enhance access to existing biologics and
fund access to novel treatments. In the case of
Omnitrope , the overall use of Omnitrope doubled
®
between 2006 and 2021, while costs only increased
by 34% in the same period.
Biosimilars can enhance the access to biologic
molecules for a larger set of patients, resulting in
improved patient outcomes and quality of life.
For example, since Omnitrope was approved by EMA
in 2006, overall somatropin usage has increased by
101%, while the overall costs have only increased
by 34% (Exhibit 17).

+ With the annual cost of drugs that treat rare
metabolic/endocrine diseases increasing by
~$2billion (57%) over the past decade for the
countries in-scope, the savings provided by
biosimilars such as Omnitrope are critical for the
sustainability of the healthcare system.
+ The variability in the uptake of the lowest cost
somatropin product across countries and the
relatively lower uptake of Omnitrope compared
to other recent biosimilars suggests that there is
additional potential for savings.
+ With more than 120 biologics losing their exclusivity
between now and 2030, the potential for biosimilars
due to these losses of exclusivity is likely to be
around $9 billion. It is crucial that the use of existing
biosimilars as well as those to come is optimized
to ensure a sustainable healthcare system where
costs are manageable, existing medicines have
appropriate access and innovative medicines can be
funded and be provided to patient.
The increase in usage of the biologic molecules suggests
that a larger set of patients are benefitting from these
important therapies. This trend is consistent with
increases in use of some other biologic molecules upon
biosimilar entry (Exhibit 17). As shown in Exhibit 18, in
the case of adalimumab and pegfilgrastim, the rate of
increase in the biologic molecule usage rose after the
launch of the biosimilar.5 This trend may be driven by
several factors, such as an increase in access due to
biosimilar entry and greater affordability; changes to
guidelines allowing for earlier use of a biologic molecule;
evolved procurement approaches; or because biologics
may have been too expensive to be reimbursed broadly
and the cost became manageable once a biosimilar
became available. However, it is important to note that
this trend is not consistently seen in all biosimilars;
some see no additional volume growth compared to
pre-biosimilar period.5

As the analysis in the previous section shows, biosimilars

such as Omnitrope hold the potential to enhance the
sustainability of healthcare ecosystems by freeing
up resources to fund innovation and to treat more
patients within the same budget, while allowing for
improvements in patient outcomes and quality of life
through enhanced access to biologics.

24 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

Exhibit 17: Somatropin sales and usage

Annual somatropin sales constant US$ Mn, 2005–2021

1,000

900

800

700
Constant US$ Mn

600 +34%
increase since
500 biosimilar
entry in 2006
400

300

200

100

0
2005 2007 2009 2011 2013 2015 2017 2019 2021

Annual somatropin defined daily doses (Mn), 2005–2021

70

60

50

40

30

20 +101%
increase since
biosimilar
10 entry in 2006

0
2005 2007 2009 2011 2013 2015 2017 2019 2021

Source: IQVIA MIDAS, Dec 2021; IQVIA Institute, May 2022.

iqviainstitute.org | 25
Exhibit 18: Changes in volume of molecule use before and after biosimilar entry

adalimumab trastuzumab
Biosimilar Impact on Biosimilar Impact on
penetration access delta penetration access delta
Bx Oct 2018 Bx Oct 2018
+14% -1%
+4%
+9% 157 177 29 30
25 26 27 28 28
53% 121 135 82 5% 56% -5%
93 100 111 91 21 15 13
116 25 26 27 28
93 100 111 121 66 94 8 14 15
20
2015 2016 2017 2018 2019 2020 2021 2015 2016 2017 2018 2019 2020 2021
bevacizumab rituximab
Bx July 2020 Bx Apr 2017
0%
+6% +1%
18 19 19 18 18 18 19

2018
65% 9 3% 78% 21 22 23 24 25 24
8
24
5
-5%
18 19 19 18 18 18 17 11
10 21 22 23 13 16 19
7
2015 2016 2017 2018 2019 2020 2021 2015 2016 2017 2018 2019 2020 2021
pegfilgrastim etanercept
Bx Oct 2018 Bx Mar 2016
+22% +3%
-6% +2%
15 18 71 73 72 73
13 12 11 12 7 62 64 66
65% 11 8 28% 54% 55 48 42 36 34 1%
13 12 11 11 10 11 62 63
7 11 23 32 36 40
1
2015 2016 2017 2018 2019 2020 2021 2015 2016 2017 2018 2019 2020 2021

Source: IQVIA MIDAS (Q2 2021).

With the annual cost of drugs that treat rare
metabolic/endocrine diseases increasing by
~$2billion (57%) over the past decade for the
countries in-scope (Exhibit 19 for overall costs), the
savings provided by biosimilars such as Omnitrope
are critical for the sustainability of the healthcare
system. These savings free up resources that can be
used to provide access to innovative therapies and to
enhance patient care.
Previous research by the IQVIA Institute has found
examples of the direct impact of savings due to
biosimilars on overall treatment of patients. For
example, in Spain, the region of Navarra is estimated
to have saved ~$11 million annually in recent years
due to the impact of biosimilar competition. This has
been reinvested in acquiring high-technology medical
equipment, improving healthcare infrastructures, and
increasing access to innovative high-cost drugs. 29

Since its approval in 2006, Omnitrope is estimated

to have resulted in $1.9 billion in savings across the
countries in-scope, with a large majority of these savings
coming in the past decade. As Exhibit 19 shows, the cost
of rare disease therapies is on the rise and has reached
more than $5 billion in the countries in scope. The savings
from Omnitrope provide flexibility for the healthcare
system to fund the latest innovations and to broaden
access to important treatments for rare diseases.

26 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

Exhibit 19: Annual sales of products treating rare metabolic/endocrine disorders across all countries in-scope
(2012–2021)

4
Constant US$ Bn

0
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

Source: IQVIA MIDAS, Dec 2021; IQVIA Institute, Jun 2022.

Notes: Select list of products based on EMA centralized approval for treatment of rare metabolic and endocrine disorder.

The potential for further savings from the use of also adopted co-payment policies that favor the use of
low-cost biosimilars such as Omnitrope exist. lower cost biosimilars in some scenarios. Such policies
The uptake of Omnitrope across different countries have generally been beneficial for the uptake of lower
varies substantially and is at 30% across all cost biosimilars in these countries as they generally
countries in scope. see greater uptake and savings. As policy measures to
increase the use of lower cost biosimilars are discussed,
Recent biosimilars have witnessed a faster uptake
it will be important to maintain the overall sustainability
while Omnitrope’s uptake as a proportion of the overall
of the market and the central role of the physician
somatropin market has not been as fast, despite being
and the patient. Certain policies, such as pharmacy
on the market for longer (Exhibit 20). In addition, as the
substitution, may impact this sustainability and shift roles
previous section showed, the uptake of Omnitrope varies
away from the physician and the patient. These policies
substantially across countries.
may not be suitable for all biosimilar markets, especially
ones such as somatropin where the treatment is
Across Europe, countries have adopted approaches to
targeting a rare disease and is often meant for children,
incentivize the use of biosimilars for physicians. Some
and where patient-physician preference is critical.
countries have issued biosimilar prescription targets to
physicians and have at times coupled them with financial
incentives to encourage physicians’ prescription of
biosimilars. For example, the UK, France and Germany
have introduced types of gainsharing programs where
a provider and a payer can split the savings achieved
from the use of the lower cost product. 30 Countries
such as Germany, Poland, Spain, and Sweden have

iqviainstitute.org | 27
Exhibit 20: Volume share of biosimilars vs originators over time
Biosimilar uptake rates in Europe quarters after launch, defined daily doses
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
0 1 2 3 4 5 6 7
Years after biosimilar launch
Source: IQVIA MIDAS, Dec 2021; IQVIA Institute, Jun 2022.
The variability in the uptake of the lowest cost
somatropin product across countries and the
relatively slower uptake of Omnitrope compared
to other recent biosimilars suggests that there is
additional potential for savings in this space.
With several innovative therapies on the horizon,
which could increase overall costs and the high cost of
COVID prevention, it is crucial for healthcare systems to
optimize savings opportunities from biosimilars. Several
factors could be impacting the final use of the lowest
cost somatropin product, as detailed below.
Lack of understanding of benefits at a prescriber
level can be a challenge
The benefits of biosimilar competition are often not
visible to all stakeholders. Savings are shared at an
aggregated level or are commercially sensitive due
to the price level submitted to a tender. Prescribers,
therefore, are rarely clear on the benefits that biosimilar
competition has provided to the healthcare system,
especially to their department.
28 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study
infliximab
bevacizumab
rituximab
pegfilgrastim
adalimumab
etanercept
trastuzumab
somatropin
8 9 10 11 12 13 14 15
Direct financial benefits are likely to face legal issues
and, in fact, would be unfavorable for physicians, risking
their freedom of choice. A more sustainable approach
involves reinvesting achieved savings in the prescriber’s
department in the hospital. This often requires the
creation of a system that can track this effectively.
As demonstrated by the regional example from Spain,
savings from biosimilars can have a direct impact on
the care for patients. Awareness and education are
the foundation for all policies; all stakeholders should
publicly advocate the benefits achieved, such as
communicating how many more patients have been
treated, the new equipment purchased, or the scale
of overall savings to be reinvested in other innovative
medicines. This demonstrates the value being provided
by biosimilar competition.
Previous reports by the IQVIA Institute have highlighted
that the level of comfort with prescribing biosimilars
varies across prescribers.49 It is critical that all
stakeholders understand the full value of biosimilars and
that physicians are comfortable prescribing them in all
markets, and in the expanding number of therapeutic In conclusion, with healthcare costs continuing to
indications. This can be achieved by educating increase, it will be critical that biosimilars are optimally
prescribers on the laboratory testing as a robust method utilized by all healthcare stakeholders to unlock the
for assessing biosimilars. A recent EMA statement that value provided by them. More than 120 biologics are
biosimilar medicines approved in the European Union losing their exclusivity between now and 2029, and the
(EU) are interchangeable with their reference medicine potential annual demand for biosimilars due to these
or with an equivalent biosimilar should help further losses of exclusivity is likely to be around $9 billion.49
alleviate concerns. A sustainable biosimilar ecosystem which fosters optimal
uptake of the lowest cost option while ensuring safety
An example of physician education can be seen in
and efficacy can help unlock savings which can then be
Denmark where to support strong biosimilar use and
utilized to support patient access to existing biologics
competition, health authorities promoted discussion
and to fund innovative treatments and support access to
groups with medical societies, prepared educational
existing treatments.
materials for both patients and physicians, prepared
existing patient databases to collect real-world
evidence (RWE) and monitored switches. These actions
contributed to increased biosimilar awareness, building
confidence and trust in biosimilars among prescribers.
A sustainable biosimilar
The approach has been to bring clinicians on the journey
proactively, rather than pressure clinicians upon the ecosystem which fosters optimal
arrival of biosimilars.49 uptake of the lowest cost option
Healthcare professionals and patient preferences while ensuring safety and
based on experience or comfort need to be well efficacy can help unlock savings
understood
Healthcare professionals and patient preferences are
which can then be utilized to
potentially a strong driver of the choice of somatropin fund innovative treatments
product. There may be important reasons for the
and support access to existing
choices made by these stakeholders, and the variation
in the uptake of Omnitrope suggests there is a need
treatments.
to understand the drivers of physician choices and
preferences further.

Given the potential for additional savings from existing

biosimilars and the large number of biosimilars on the
horizon, it will be important for countries to create a
conducive environment for the adoption of lower priced
products. A greater understanding of physician and
patient preferences can help ensure that such policies
are designed in a thoughtful manner that considers the
perspectives of all stakeholders.

iqviainstitute.org | 29
Notes on sources
THIS REPORT IS BASED ON THE IQVIA SERVICES
DETAILED BELOW

IQVIA MIDAS® is a unique data platform for assessing

worldwide healthcare markets. It integrates IQVIA
national audits into a globally consistent view of the
pharmaceutical market, tracking virtually every product
in hundreds of therapeutic classes and providing
estimated product volumes, trends and market share
through retail and non-retail channels. MIDAS data
is updated monthly and retains 12 years of history.
Additional years were gathered through archived data.

30 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

Appendix
METHODOLOGY FOR ASSESSING 15 YEARS OF SAVINGS
AND USE
The objective of this analysis is to provide a broad
overview of the evolution of somatropin market after the
entry of a biosimilar, Omnitrope®. This involves assessing
the total use of Omnitrope (and somatropin products)
and the savings due to the entry of Omnitrope (from
2006 to 2021) across several European countries
(See Table 1 for full list of countries).
The following dataset was utilized to conduct this
analysis
• IQVIA MIDAS® is a unique platform for assessing
worldwide healthcare markets. It integrates IQVIA’s
national audits into a globally consistent view of
the pharmaceutical market, tracking virtually every
product in hundreds of therapeutic classes, and
provides estimated product volumes, trends and
market share through retail and non-retail channels.
MIDAS data are updated quarterly and retain 12
years of data. Historic archives of MIDAS were used
to extend analyses to the full time period analyzed,
2005 to 2021.
The key variables utilized from the dataset are as follows –
• Sales – sales by product in local currency at the
ex-manufacturer level. For comparison across
countries, local currency sales were converted to
constant US dollars using Q4 2021 exchange rates.
Because sales reflect ex-manufacturer price levels,
this does not consider rebates or discounts, and
does not reflect the amounts payers and/or patients
pay for medicines.
• Volume – volume is measured in Defined Daily
Doses. The term patient-years is also used which
is the Defined Daily Dose/365. The World Health
Organization (WHO) has developed a method
of normalizing medicines of varying intended
doses using defined daily doses (WHO-DDD).
The WHO-DDD measure is intended to most
often represent a standard day of therapy for
a maintenance dose of a chronic therapy. The
WHO-DDD measure does not reflect actual
treatment decisions and is not derived from distinct
patients measured with anonymized data. The
WHO-DDD guidance is provided online (see https://
www.whocc.no/atc_ddd_index/) but does not
include factors or guidance for all drug products.
Distinct numeric factors are provided in relation
to milligrams or international units (IU) depending
on the medicine, or in terms of number of pills
per day in the case of chronic medicines such as
hypertension. WHO provides guiding principles
for calculating DDDs for fixed-dose combination
products. The IQVIA institute has developed
additional factors using the same or highly similar
concepts to represent more than 99% of audited
standard unit volume for the biosimilar market
shown in this analysis. DDDs have been estimated
for other products based on the standard unit
to DDD ratios per product type, where specific
DDD values had already been determined. The
WHO-DDD for somatropin in 2IU and is “based on
the treatment of growth retardation in children with
a body weight of 25kg.”
iqviainstitute.org | 31
In the analysis presented, biosimilars are compared To estimate the savings associated with the entry of the
to biosimilar accessible market which is defined as the biosimilar, we compare the actual sales that took place
following two components with the hypothetical scenario where the biosimilar is not
available in the market and therefore, the somatropin
• Referenced Medicinal Product (Original product,
price per DDD stays constant at pre-expiry prices across
granted market exclusivity at the start of its life,
the time period. Previous study has found that originator
exclusivity has now expired, and the product
prices did not vary substantially prior to the originator
has been categorized as referenced by having
launch, allowing for a constant price assumption. This
a biosimilar with an EMA-approved marketing
approach to calculate the savings has been previously
authorization available on a European market.),
adopted in studies which assessed savings from
biosimilars in individual countries. This approach allows
• Non-Referenced Medicinal Product (Original,
us to account for savings due to the lower price of the
or second generation, product granted market
biosimilar as well as the potentially lower price of the
exclusivity at the start of its life, exclusivity has now
other somatropin products due to the increased price
expired, and the product has never been categorized
competition from the biosimilar.
as a Referenced Medicinal product by a biosimilar
receiving centrally approved marketing authorization)

Table 1: Countries included in somatropin analysis

Austria Belgium Bulgaria Croatia Czech Republic

Denmark* Estonia Finland France Germany

Hungary Italy Kazakhstan Lithuania Luxembourg

Netherlands* Norway Poland Portugal Romania

Russia Slovenia Spain Sweden Switzerland

UK

* Sales and volume data projected for Netherlands (Q3 2009-Q1 2013) and Denmark (Q3 and Q4 2009) due to irregularities in data captured in MIDAS.

Table 2: Countries excluded from somatropin analysis

Country Reason for Exclusion

Cyprus Not audited by IQVIA

Greece No somatropin biosimilar sales observed

Iceland Not audited by IQVIA

Ireland No somatropin biosimilar sales observed

Latvia IQVIA data incomplete for 2011-2013

Liechtenstein Not audited by IQVIA

Malta Not audited by IQVIA

Slovakia No somatropin biosimilar sales observed

* Sales and volume data projected for Netherlands (Q3 2009-Q1 2013) and Denmark (Q3 and Q4 2009) due to irregularities in data captured in MIDAS.

32 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Austria, 2006–2021
Annual
Annual
Exhibit 21A: Annual somatropin
somatropin
somatropin sales
sales
sales Exhibit 21B: Annual somatropin DDDs
18
18 800
800

15
15

+144%
+144% +161%
+161%
US$ Mn
Mn

600
600
12
12
Constant US$

increase
increase increase
increase

Millions
Millions
since
since since
since
99 400
400
Constant

biosimilar
biosimilar biosimilar
biosimilar
entry
entryinin entry
entryinin
66 2007
2007 2007
2007
200
200
33

00 00
2006
2006 2011
2011 2016
2016 2021
2021 2006
2006 2011
2011 2016
2016 2021
2021

Exhibit 21C: Cumulative Omnitrope patient years Exhibit 21D: Omnitrope share of somatropin DDDs

2,000
2,000 20%
20%

1,500
1,500 15%
15%
10%
10%
1,816
1,816 of
of
somatropin
somatropin
patient
patient
1,000
1,000 years
years 10%
10% use
useisis
Omnitrope
Omnitrope

500
500 5%
5%

00 0%
0%
2006
2006 2011
2011 2016
2016 2021
2021 2006
2006 2011
2011 2016
2016 2021
2021

Exhibit 21E: Cumulative savings after biosimilar entry

-2
Constant US$ Mn

$9.0Mn
-4 in savings
following
biosimilar
-6 entry in
2006
-8

-10
2006 2011 2016 2021 2006 2011 2016

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

iqviainstitute.org | 33
 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Belgium, 2007–2021
Annual
Annual
Exhibit 22A: Annual somatropin
somatropin
somatropin sales
sales
sales Exhibit 22B: Annual somatropin DDDs
30
30 2.0
2.0

25
25

-1%
-1% +43%
+43%
US$ Mn
Mn

1.5
1.5
20
20
Constant US$

decrease
decrease increase
increase

Millions
Millions
since
since since
since
15
15 1.0
1.0
Constant

biosimilar
biosimilar biosimilar
biosimilar
entry
entryinin entry
entryinin
10
10 2008
2008 2008
2008
0.5
0.5
55

00 0.0
0.0
2007
2007 2009
2009 2011
2011 2013
2013 2015
2015 2019
2019 2021
2021 2007
2007 2009
2009 2011
2011 2013
2013 2015
2015 2019
2019 2021
2021

Exhibit 22C: Cumulative Omnitrope patient years Exhibit 22D: Omnitrope share of somatropin DDDs

7,000
7,000 25%
25%

6,000
6,000
20%
20%
5,000
5,000 22%
22%
4,000
4,000
5,874
5,874 15%
15% of
of
somatropin
somatropin
patient
patient
years
years use
useisis
3,000
3,000 10%
10% Omnitrope
Omnitrope
2,000
2,000
5%
5%
1,000
1,000

00 0%
0%
2007
2007 2009
2009 2011
2011 2013
2013 2015
2015 2019
2019 2021
2021 2007
2007 2009
2009 2011
2011 2013
2013 2015
2015 2019
2019 2021
2021

Exhibit 22E: Cumulative savings after biosimilar entry

-10
Constant US$ Mn

$49Mn
-20 in savings
following
biosimilar
-30 entry in
2008
-40

-50
2007 2009 2011 2013 2015 2019 2021 2006 2009 2011 2013 2015

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

34 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Bulgaria, 2011–2021
Annual
Annual
Exhibit 23A: Annual somatropin
somatropin
somatropin sales
sales
sales Exhibit 23B: Annual somatropin DDDs

3.0
3.0 300
300

2.5
2.5 250
250
+14%
+14% +49%
+49%
US$ Mn
Mn

2.0
2.0 200
200
Constant US$

increase
increase increase
increase

Thousands
Thousands
since
since since
since
1.5
1.5 150
150
Constant

biosimilar
biosimilar biosimilar
biosimilar
entry
entryinin entry
entryinin
1.0
1.0 2012
2012 100
100 2012
2012

0.5
0.5 50
50

0.0
0.0 00
2011
2011 2013
2013 2015
2015 2017
2017 2019
2019 2021
2021 2011
2011 2013
2013 2015
2015 2017
2017 2019
2019 2021
2021

Exhibit 23C: Cumulative Omnitrope patient years Exhibit 23D: Omnitrope share of somatropin DDDs

1,600
1,600 60%
60%
1,400
1,400
50%
50%
1,200
1,200
49%
49%
1,000
1,000 1,556
1,556 40%
40% of
of
somatropin
somatropin
patient
patient
800
800 years
years 30%
30% use
useisis
Omnitrope
Omnitrope
600
600
20%
20%
400
400
10%
10%
200
200
00 0%
0%
2011
2011 2013
2013 2015
2015 2017
2017 2019
2019 2021
2021 2011
2011 2013
2013 2015
2015 2017
2017 2019
2019 2021
2021

Exhibit 23E: Cumulative savings after biosimilar entry

-1
Constant US$ Mn

$4.9Mn
-2 in savings
following
biosimilar
-3 entry in
2012
-4

-5
2011 2013 2015 2017 2019 2021 2011 2013 2015 2017 2

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

iqviainstitute.org | 35
 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Croatia, 2014–2021
Annual
Annual
Exhibit 24A: Annual somatropin
somatropin
somatropin sales
sales
sales Exhibit 24B: Annual somatropin DDDs

44 300
300

250
250
+37%
+37% +87%
+87%
US$ Mn
Mn

33
200
200
Constant US$

increase
increase increase
increase

Thousands
Thousands
since
since since
since
22 150
150
Constant

biosimilar
biosimilar biosimilar
biosimilar
entry
entryinin entry
entryinin
2015
2015 100
100 2015
2015
11
50
50

00 00
2014
2014 2015
2015 2016
2016 2017
2017 2018
2018 2019
2019 2020
2020 2021
2021 2014
2014 2015
2015 2016
2016 2017
2017 2018
2018 2019
2019 2020
2020 2021
2021

Exhibit 24C: Cumulative Omnitrope patient years Exhibit 24D: Omnitrope share of somatropin DDDs

800
800 25%
25%

20%
20%
600
600
21%
21%
718
718 15%
15% of
of
somatropin
somatropin
patient
patient
400
400 years
years use
useisis
10%
10% Omnitrope
Omnitrope

200
200
5%
5%

00 0%
0%
2014
2014 2015
2015 2016
2016 2017
2017 2018
2018 2019
2019 2020
2020 2021
2021 2014
2014 2015
2015 2016
2016 2017
2017 2018
2018 2019
2019 2020
2020 2021
2021

Exhibit 24E: Cumulative savings after biosimilar entry

$3.8Mn
Constant US$ Mn

-1
in savings
following
-2 biosimilar
entry in
2015
-3

-4
2014 2015 2016 2017 2018 2019 2020 2021 2014 2015 2016 2017 2018 2019

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

36 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Czech Republic, 2009–2021

Annual
Annual
Exhibit 25A: Annual somatropin
somatropin
somatropin sales
sales
sales Exhibit 25B: Annual somatropin DDDs

25
25 2.0
2.0

20
20
+52%
+52% +110%
+110%
US$ Mn
Mn

1.5
1.5
Constant US$

increase
increase increase
increase
15
15

Millions
Millions
since
since since
since
1.0
1.0
Constant

biosimilar
biosimilar biosimilar
biosimilar
10
10 entry
entryinin entry
entryinin
2010
2010 2010
2010
0.5
0.5
55

00 0.0
0.0
2009
2009 2012
2012 2015
2015 2018
2018 2021
2021 2009
2009 2012
2012 2015
2015 2018
2018 2021
2021

Exhibit 25C: Cumulative Omnitrope patient years Exhibit 25D: Omnitrope share of somatropin DDDs

2,500
2,500 10%
10%

2,000
2,000 8%
8%
8%
8%
1,500
1,500 2,299
2,299 6%
6% of
of
somatropin
somatropin
patient
patient
years
years use
useisis
1,000
1,000 4%
4% Omnitrope
Omnitrope

500
500 2%
2%

00 0%
0%
2009
2009 2012
2012 2015
2015 2018
2018 2021
2021 2009
2009 2012
2012 2015
2015 2018
2018 2021
2021

Exhibit 25E: Cumulative savings after biosimilar entry

-10
Constant US$ Mn

-20 $58Mn
in savings
following
-30 biosimilar
entry in
-40 2010

-50

-60
2008 2010 2012 2014 2016 2018 2021 2008 2010 2012 2014 2016

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

iqviainstitute.org | 37
 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Estonia, 2012–2021
Annual
Annual
Exhibit 26A: Annual somatropin
somatropin
somatropin sales
sales
sales Exhibit 26B: Annual somatropin DDDs

1.2
1.2 100
100

80
80
-49%
-49% -32%
-32%
US$ Mn
Mn

0.9
0.9
Constant US$

decrease
decrease decrease
decrease

Thousands
Thousands
since
since 60
60 since
since
0.6
0.6
Constant

biosimilar
biosimilar biosimilar
biosimilar
entry
entryinin 40
40 entry
entryinin
2013
2013 2013
2013
0.3
0.3
20
20

0.0
0.0 00
2012
2012 2015
2015 2018
2018 2021
2021 2012
2012 2015
2015 2018
2018 2021
2021

Exhibit 26C: Cumulative Omnitrope patient years Exhibit 26D: Omnitrope share of somatropin DDDs

180
180 25%
25%

150
150 20%
20%
10%
10%
120
120
166
166 15%
15%
of
of
somatropin
somatropin
patient
patient
90
90 years
years use
useisis
10%
10% Omnitrope
Omnitrope
60
60

30
30 5%
5%

00 0%
0%
2012
2012 2015
2015 2018
2018 2021
2021 2012
2012 2015
2015 2018
2018 2021
2021

Exhibit 26E: Cumulative savings after biosimilar entry

0.0

-0.3
Constant US$ Mn

$1.4Mn
-0.6 in savings
following
biosimilar
-0.9 entry in
2013
-1.2

-1.5
2012 2015 2018 2021 2012 2015 2018

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

38 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Hungary, 2010–2021
Annual
Annual
Exhibit 27A: Annual somatropin
somatropin
somatropin sales
sales
sales Exhibit 27B: Annual somatropin DDDs

88 700
700

600
600
-15%
-15% +22%
+22%
US$ Mn
Mn

66 500
500
Constant US$

decrease
decrease increase
increase

Thousands
Thousands
since
since 400
400 since
since
Constant

44 biosimilar
biosimilar biosimilar
biosimilar
entry
entryinin 300
300 entry
entryinin
2011
2011 2011
2011
200
200
22
100
100
00 00
2010
2010 2012
2012 2014
2014 2016
2016 2018
2018 2021
2021 2010
2010 2012
2012 2014
2014 2016
2016 2018
2018 2021
2021

Exhibit 27C: Cumulative Omnitrope patient years Exhibit 27D: Omnitrope share of somatropin DDDs

1,000
1,000 15%
15%

800
800 12%
12%
12%
12%
600
600 944
944 9%
9% of
of
somatropin
somatropin
patient
patient
years
years use
useisis
400
400 6%
6% Omnitrope
Omnitrope

200
200 3%
3%

00 0%
0%
2010
2010 2012
2012 2014
2014 2016
2016 2018
2018 2021
2021 2010
2010 2012
2012 2014
2014 2016
2016 2018
2018 2021
2021

Exhibit 27E: Cumulative savings after biosimilar entry

0.0

-0.5
Constant US$ Mn

-1.0
$2.8Mn
in savings
following
-1.5 biosimilar
entry in
-2.0 2011

-2.5

-3.0
2010 2012 2014 2016 2018 2021 2010 2012 2014 2016 201

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

iqviainstitute.org | 39
 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Kazakhstan, 2015–2021
Annual
Annual
Exhibit 28A: Annual somatropin
somatropin
somatropin sales
sales
sales Exhibit 28B: Annual somatropin DDDs

44 600
600

500
500
+16%
+16% +60%
+60%
US$ Mn
Mn

33
400
400
Constant US$

increase
increase increase
increase

Thousands
Thousands
since
since since
since
22 300
300
Constant

biosimilar
biosimilar biosimilar
biosimilar
entry
entryinin entry
entryinin
2016
2016 200
200 2016
2016
11
100
100

00 00
2015
2015 2016
2016 2017
2017 2018
2018 2019
2019 2020
2020 2021
2021 2015
2015 2016
2016 2017
2017 2018
2018 2019
2019 2020
2020 2021
2021

Exhibit 28C: Cumulative Omnitrope patient years Exhibit 28D: Omnitrope share of somatropin DDDs

1,600
1,600 60%
60%
1,400
1,400
50%
50%
1,200
1,200
34%
34%
1,000
1,000 1,508
1,508 40%
40% of
of
somatropin
somatropin
patient
patient
800
800 years
years 30%
30% use
useisis
Omnitrope
Omnitrope
600
600
20%
20%
400
400
10%
10%
200
200
00 0%
0%
2015
2015 2016
2016 2017
2017 2018
2018 2019
2019 2020
2020 2021
2021 2015
2015 2016
2016 2017
2017 2018
2018 2019
2019 2020
2020 2021
2021

Exhibit 28E: Cumulative savings after biosimilar entry

-1
$5.0
Constant US$ Mn

-2

-3
Mn
in savings
following
-4 biosimilar
entry in
-5 2015

-6
2015 2016 2017 2018 2019 2020 2021 2015 2016 2017 2018 2019

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

40 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Lithuania, 2012–2021
Annual
Annual
Exhibit 29A: Annual somatropin
somatropin
somatropin sales
sales
sales Exhibit 29B: Annual somatropin DDDs

44 300
300

250
250
-29%
-29% -2%
-2%
US$ Mn
Mn

33
200
200
Constant US$

decrease
decrease decrease
decrease

Thousands
Thousands
since
since since
since
22 150
150
Constant

biosimilar
biosimilar biosimilar
biosimilar
entry
entryinin entry
entryinin
2013
2013 100
100 2013
2013
11
50
50

00 00
2012
2012 2015
2015 2018
2018 2021
2021 2012
2012 2015
2015 2018
2018 2021
2021

Exhibit 29C: Cumulative Omnitrope patient years Exhibit 29D: Omnitrope share of somatropin DDDs

250
250 10%
10%

200
200 8%
8%
4%
4%
150
150 203
203 6%
6% of
of
somatropin
somatropin
patient
patient
years
years use
useisis
100
100 4%
4% Omnitrope
Omnitrope

50
50 2%
2%

00 0%
0%
2012
2012 2015
2015 2018
2018 2021
2021 2012
2012 2015
2015 2018
2018 2021
2021

Exhibit 29E: Cumulative savings after biosimilar entry

-1
Constant US$ Mn

-2 $5.3Mn
in savings
following
-3 biosimilar
entry in
-4 2013

-5

-6
2012 2015 2018 2021 2012 2015 2018

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

iqviainstitute.org | 41
 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Luxembourg, 2010–2021
Annual
Annual
Exhibit 30A: Annual somatropin
somatropin
somatropin sales
sales
sales Exhibit 30B: Annual somatropin DDDs

1.0
1.0 50
50

0.8
0.8 40
40
-0.3%
-0.3% +37%
+37%
US$ Mn
Constant US$ Mn

decrease
decrease increase
increase

Thousands
Thousands
0.6
0.6 since
since 30
30 since
since
Constant

biosimilar
biosimilar biosimilar
biosimilar
0.4
0.4 entry
entryinin 20
20 entry
entryinin
2011
2011 2011
2011

0.2
0.2 10
10

0.0
0.0 00
2010
2010 2012
2012 2014
2014 2016
2016 2018
2018 2021
2021 2010
2010 2012
2012 2014
2014 2016
2016 2018
2018 2021
2021

Exhibit 30C: Cumulative Omnitrope patient years Exhibit 30D: Omnitrope share of somatropin DDDs

120
120 25%
25%

100
100 20%
20%
22%
22%
80
80
96
96 15%
15% of
of
somatropin
somatropin
patient
patient
60
60 years
years use
useisis
10%
10% Omnitrope
Omnitrope
40
40

20
20 5%
5%

00 0%
0%
2010
2010 2012
2012 2014
2014 2016
2016 2018
2018 2021
2021 2010
2010 2012
2012 2014
2014 2016
2016 2018
2018 2021
2021

Exhibit 30E: Cumulative savings after biosimilar entry

0.0

-0.2
Constant US$ Mn

$1.0Mn
-0.4 in savings
following
biosimilar
-0.6 entry in
2011
-0.8

-1.0
2010 2012 2014 2016 2018 2021 2010 2012 2014 2016 201

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

42 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Netherlands, 2007–2021
Annual
Annual
Exhibit 31A: Annual somatropin
somatropin
somatropin sales
sales
sales Exhibit 31B: Annual somatropin DDDs

60
60 2.5
2.5
50
50
2.0
2.0
-14%
-14% +57%
+57%
US$ Mn
Mn

40
40
Constant US$

decrease
decrease increase
increase
1.5
1.5

Millions
Millions
since
since since
since
30
30
Constant

biosimilar
biosimilar biosimilar
biosimilar
entry
entryinin 1.0
1.0 entry
entryinin
20
20 2006
2006 2006
2006

10
10 0.5
0.5

00 0.0
0.0
2005
2005 2009
2009 2013
2013 2017
2017 2021
2021 2005
2005 2009
2009 2013
2013 2017
2017 2021
2021

2006
2006 2011
2011 2016
2016 2021
2021

Exhibit 31C: Cumulative Omnitrope patient years Exhibit 31D: Omnitrope share of somatropin DDDs

10,000
10,000 40%
40%

8,000
8,000
30%
30% 34%
34%
6,000
6,000 8,823
8,823 of
of
somatropin
somatropin
patient
patient
years
years 20%
20% use
useisis
4,000
4,000 Omnitrope
Omnitrope

10%
10%
2,000
2,000

00 0%
0%
2005
2005 2009
2009 2013
2013 2017
2017 2021
2021 2005
2005 2009
2009 2013
2013 2017
2017 2021
2021

Exhibit 31E: Cumulative savings after biosimilar entry

-50
Constant US$ Mn

$226Mn
-100 in savings
following
biosimilar
-150 entry in
2006
-200

-250
2005 2009 2013 2017 2021 2006 2011 2016

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

iqviainstitute.org | 43
 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Poland, 2007–2021
Annual
Annual
Exhibit 32A: Annual somatropin
somatropin
somatropin sales
sales
sales Exhibit 32B: Annual somatropin DDDs

32
32 55
28
28
44
24
24
+52%
+52% +170%
+170%
US$ Mn
Constant US$ Mn

20
20 increase
increase 33 increase
increase

Millions
Millions
since
since since
since
16
16
Constant

biosimilar
biosimilar biosimilar
biosimilar
12
12 entry
entryinin 22 entry
entryinin
2008
2008 2008
2008
88
11
44
00 00
2007
2007 2009
2009 2011
2011 2013
2013 2015
2015 2019
2019 2021
2021 2007
2007 2009
2009 2011
2011 2013
2013 2015
2015 2019
2019 2021
2021

Exhibit 32C: Cumulative Omnitrope patient years Exhibit 32D: Omnitrope share of somatropin DDDs

100,000
100,000 100%
100%

80,000
80,000 80%
80%
99%
99%
60,000
60,000 88,300
88,300 60%
60% of
of
somatropin
somatropin
patient
patient
years
years use
useisis
40,000
40,000 40%
40% Omnitrope
Omnitrope

20,000
20,000 20%
20%

00 0%
0%
2007
2007 2009
2009 2011
2011 2013
2013 2015
2015 2019
2019 2021
2021 2007
2007 2009
2009 2011
2011 2013
2013 2015
2015 2019
2019 2021
2021

Exhibit 32E: Cumulative savings after biosimilar entry

-10
Constant US$ Mn

$38Mn
-20 in savings
following
biosimilar
-30 entry in
2008
-40

-50
2007 2009 2011 2013 2015 2019 2021 2006 2009 2011 2013 2015

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

44 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Portugal, 2013–2021
Annual
Annual
Exhibit 33A: Annual somatropin
somatropin
somatropin sales
sales
sales Exhibit 33B: Annual somatropin DDDs

12
12 600
600

10
10 500
500
-39%
-39% +8%
+8%
US$ Mn
Mn

88 400
400
Constant US$

decrease
decrease increase
increase

Thousands
Thousands
since
since since
since
66 300
300
Constant

biosimilar
biosimilar biosimilar
biosimilar
entry
entryinin entry
entryinin
44 2014
2014 200
200 2014
2014

22 100
100

00 00
2013
2013 2015
2015 2017
2017 2019
2019 2021
2021 2013
2013 2015
2015 2017
2017 2019
2019 2021
2021

Exhibit 33C: Cumulative Omnitrope patient years Exhibit 33D: Omnitrope share of somatropin DDDs

1,400
1,400 35%
35%

1,200
1,200 30%
30%

1,000
1,000 25%
25% 31%
31%
800
800
1,208
1,208 20%
20%
of
of
somatropin
somatropin
patient
patient
years
years use
useisis
600
600 15%
15% Omnitrope
Omnitrope
400
400 10%
10%

200
200 5%
5%

00 0%
0%
2013
2013 2015
2015 2017
2017 2019
2019 2021
2021 2013
2013 2015
2015 2017
2017 2019
2019 2021
2021

Exhibit 33E: Cumulative savings after biosimilar entry

-5
Constant US$ Mn

$8.0Mn
-10 in savings
following
biosimilar
-15 entry in
2013
-20

-25
2013 2015 2017 2019 2021 2013 2015 2017 201

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

iqviainstitute.org | 45
 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Romania, 2007–2021
Annual
Annual
Exhibit 34A: Annual somatropin
somatropin
somatropin sales
sales
sales Exhibit 34B: Annual somatropin DDDs

15
15 1.5
1.5

12
12 1.2
1.2
+38%
+38% +105%
+105%
US$ Mn
Constant US$ Mn

99 increase
increase 0.9
0.9 increase
increase

Millions
Millions
since
since since
since
Constant

biosimilar
biosimilar biosimilar
biosimilar
66 entry
entryinin 0.6
0.6 entry
entryinin
2008
2008 2008
2008

33 0.3
0.3

00 0.0
0.0
2007
2007 2009
2009 2011
2011 2013
2013 2015
2015 2019
2019 2021
2021 2007
2007 2009
2009 2011
2011 2013
2013 2015
2015 2019
2019 2021
2021

Exhibit 34C: Cumulative Omnitrope patient years Exhibit 34D: Omnitrope share of somatropin DDDs

12,000
12,000 50%
50%

10,000
10,000
40%
40%
99%
99%
8,000
8,000
10,538
10,538 30%
30%
of
of
somatropin
somatropin
patient
patient
6,000
6,000 years
years use
useisis
20%
20% Omnitrope
Omnitrope
4,000
4,000

2,000
2,000 10%
10%

00 0%
0%
2007
2007 2009
2009 2011
2011 2013
2013 2015
2015 2019
2019 2021
2021 2007
2007 2009
2009 2011
2011 2013
2013 2015
2015 2019
2019 2021
2021

Exhibit 34E: Cumulative savings after biosimilar entry

-10
Constant US$ Mn

$48Mn
-20 in savings
following
biosimilar
-30 entry in
2008
-40

-50
2007 2009 2011 2013 2015 2019 2021 2006 2009 2011 2013 2015

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

46 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Russia, 2012–2021
Annual
Annual
Exhibit 35A: Annual somatropin
somatropin
somatropin sales
sales
sales Exhibit 35B: Annual somatropin DDDs

66 3.0
3.0

55 2.5
2.5
-4%
-4% +36%
+36%
US$ Mn
Mn

44 2.0
2.0
Constant US$

decrease
decrease increase
increase

Millions
Millions
since
since since
since
33 1.5
1.5
Constant

biosimilar
biosimilar biosimilar
biosimilar
entry
entryinin entry
entryinin
22 2013
2013 1.0
1.0 2013
2013

11 0.5
0.5

00 0.0
0.0
2012
2012 2015
2015 2018
2018 2021
2021 2012
2012 2015
2015 2018
2018 2021
2021

Exhibit 35C: Cumulative Omnitrope patient years Exhibit 35D: Omnitrope share of somatropin DDDs

3,000
3,000 14%
14%

2,500
2,500 12%
12%

10%
10% 13%
13%
2,000
2,000
2,587
2,587 8%
8%
of
of
somatropin
somatropin
patient
patient
1,500
1,500 years
years use
useisis
6%
6% Omnitrope
Omnitrope
1,000
1,000
4%
4%
500
500 2%
2%

00 0%
0%
2012
2012 2015
2015 2018
2018 2021
2021 2012
2012 2015
2015 2018
2018 2021
2021

Exhibit 35E: Cumulative savings after biosimilar entry

-2
Constant US$ Mn

$8.0Mn
-4 in savings
following
biosimilar
-6 entry in
2013
-8

-10
2012 2015 2018 2021 2012 2015 2018

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

iqviainstitute.org | 47
 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Slovenia, 2008–2021
Annual
Annual
Exhibit 36A: Annual somatropin
somatropin
somatropin sales
sales
sales Exhibit 36B: Annual somatropin DDDs

3.0
3.0 250
250

2.5
2.5 200
200
+17%
+17% +80%
+80%
US$ Mn
Mn

2.0
2.0
Constant US$

increase
increase increase
increase

Thousands
Thousands
150
150
since
since since
since
1.5
1.5
Constant

biosimilar
biosimilar biosimilar
biosimilar
entry
entryinin 100
100 entry
entryinin
1.0
1.0 2009
2009 2009
2009

0.5
0.5 50
50

0.0
0.0 00
2008
2008 2010
2010 2012
2012 2014
2014 2016
2016 2018
2018 2021
2021 2008
2008 2010
2010 2012
2012 2014
2014 2016
2016 2018
2018 2021
2021

Exhibit 36C: Cumulative Omnitrope patient years Exhibit 36D: Omnitrope share of somatropin DDDs

300
300 10%
10%

250
250 8%
8%
9%
9%
200
200
247
247 6%
6% of
of
somatropin
somatropin
patient
patient
150
150 years
years use
useisis
4%
4% Omnitrope
Omnitrope
100
100
2%
2%
50
50

00 0%
0%
2008
2008 2010
2010 2012
2012 2014
2014 2016
2016 2018
2018 2021
2021 2008
2008 2010
2010 2012
2012 2014
2014 2016
2016 2018
2018 2021
2021

Exhibit 36E: Cumulative savings after biosimilar entry

-2
Constant US$ Mn

-4
$11Mn
in savings
following
-6 biosimilar
entry in
-8 2009

-10

-12
2008 2010 2012 2014 2016 2018 2021 2008 2010 2012 2014 2016

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

48 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Sweden, 2005–2021
Annual
Annualsomatropin
somatropinsales
sales
Exhibit 37A: Annual somatropin sales Exhibit 37B: Annual somatropin DDDs
40
40 2.5
2.5
35
35
2.0
2.0
-50%
-50% -41%
-41%
US$ Mn
Mn

30
30
Constant US$

25
25 decrease
decrease decrease
decrease
1.5
1.5

Millions
Millions
since
since since
since
20
20
Constant

biosimilar
biosimilar biosimilar
biosimilar
entry
entryinin 1.0
1.0 entry
entryinin
15
15 2006
2006 2006
2006
10
10
0.5
0.5
55
00 0.0
0.0
2005
2005 2009
2009 2013
2013 2017
2017 2021
2021 2005
2005 2009
2009 2013
2013 2017
2017 2021
2021

Exhibit 37C: Cumulative Omnitrope patient years Exhibit 37D: Omnitrope share of somatropin DDDs

12,000
12,000 50%
50%

10,000
10,000 40%
40%
40%
40%
8,000
8,000
10,481
10,481 30%
30% ofof
somatropin
somatropin
patient
patient
6,000
6,000 years
years use
useisis
20%
20% Omnitrope
Omnitrope
4,000
4,000
10%
10%
2,000
2,000

00 0%
0%
2005
2005 2009
2009 2013
2013 2017
2017 2021
2021 2005
2005 2009
2009 2013
2013 2017
2017 2021
2021

Exhibit 37E: Annual somatropin savings by product in Sweden, constant US$ Mn, 2006-2021 and Omnitrope
Market Share

10 100%
90%
$1.4Mn
in savings following
5 biosimilar entry in 2007
80%
Constant US$ Mn

0 70% Zomacton
60% Saizen
-5 50% Omnitrope
40%
-10 Nutropinaq
30%
Norditropin
20%
-15 Humatrope
10%
Genotropin
-20 0%
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 Omnitrope share

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here. Sweden saw an increase in costs
initially but this has started to decline in subsequent years. However, overall savings were limited.

iqviainstitute.org | 49
 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

Switzerland, 2009–2021
Annual
Annual
Exhibit 38A: Annual somatropin
somatropin
somatropin sales
sales
sales Exhibit 38B: Annual somatropin DDDs

35
35 1.0
1.0
30
30
0.8
0.8
-17%
-17% +47%
+47%
US$ Mn
Mn

25
25
Constant US$

decrease
decrease increase
increase
0.6
0.6

Millions
Millions
20
20 since
since since
since
Constant

biosimilar
biosimilar biosimilar
biosimilar
15
15 entry
entryinin 0.4
0.4 entry
entryinin
2010
2010 2010
2010
10
10
0.2
0.2
55

00 0.0
0.0
2009
2009 2012
2012 2015
2015 2018
2018 2021
2021 2009
2009 2012
2012 2015
2015 2018
2018 2021
2021

Exhibit 38C: Cumulative Omnitrope patient years Exhibit 38D: Omnitrope share of somatropin DDDs

1,200
1,200 10%
10%

1,000
1,000 8%
8%
7%
7%
800
800
1,051
1,051 6%
6% of
of
somatropin
somatropin
patient
patient
600
600 years
years use
useisis
4%
4% Omnitrope
Omnitrope
400
400

200
200 2%
2%

00 0%
0%
2009
2009 2012
2012 2015
2015 2018
2018 2021
2021 2009
2009 2012
2012 2015
2015 2018
2018 2021
2021

Exhibit 38E: Cumulative savings after biosimilar entry

-20
Constant US$ Mn

-40
$115Mn
in savings
following
-60 biosimilar
entry in
-80 2010

-100

-120
2009 2012 2015 2018 2021 2009 2012 2015 201

Source: IQVIA MIDAS, Jan 2022; IQVIA Institute, May 2022.

Notes: Savings refer to savings at a list price level. Additional discounts, rebates may be used that are not captured here.

50 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

 APPENDIX: USE AND SAVINGS ASSOCIATED WITH OMNITROPE AT A COUNTRY LEVEL

The total impact of biosimilar competition is €18Bn at list prices

Exhibit 39: The past 5-years is responsible for 90% of the savings, and likely underestimates the impact

Cumulative impact of biosimilar competition on cost

(Cost for post-biosimilar volume at pre-biosimilar list prices)
18,000
16,000
Value (LCEuros, Millions)

14,000
12,000
10,000
8,000
6,000
4,000
2,000
0
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

Source: IQVIA MIDAS™ data from 2006 – 2020, using Euros at constant exchange rates; 14 originator products with approved biosimilars from 2006 – 2020
(includes biosimilar and originator), covering the full European Economic Area (33 CTYs), calculated volume is in treatment days determined by WHO-DDD,
and where values are unavailable via Oncology Dynamics Physician Survey (2017) DDD estimates.
Notes: This figure is not equivalent to savings. The data does not include the impact of rebates or discounts, which may have been present prior to the
introduction of biosimilars in small quantities, and are highly significant post-biosimilar entry as it is based on publicly available list prices.

iqviainstitute.org | 51
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iqviainstitute.org | 53
About the authors
MURRAY AITKEN VIBHU TEWARY
Executive Director, Project Director, IQVIA Institute for
IQVIA Institute for Human Human Data Science
Data Science

Murray Aitken is Executive Director, IQVIA Institute Vibhu Tewary is a Project Director at the IQVIA Institute
for Human Data Science, which provides policy setters for Human Data Science and is based out of New York,
and decisionmakers in the global health sector with NY. His key areas of interest include healthcare policy,
objective insights into healthcare dynamics. He led global market access, and economic modeling. Vibhu has
the IMS Institute for Healthcare Informatics, now the authored multiple reports on global healthcare policy
IQVIA Institute, since its inception in January 2011. and market access. Prior to joining IQVIA, he worked as
Murray previously was Senior Vice President, Healthcare a researcher in a policy think tank in India. Vibhu did his
Insight, leading IMS Health’s thought leadership undergraduate studies at the Indian Institute
initiatives worldwide. Before that, he served as Senior of Technology, Madras, and holds an MBA from
Vice President, Corporate Strategy, from 2004 to 2007.
Duke University.
Murray joined IMS Health in 2001 with responsibility
for developing the company’s consulting and services
businesses. Prior to IMS Health, Murray had a 14-year
career with McKinsey & Company, where he was a leader
in the Pharmaceutical and Medical Products practice
from 1997 to 2001. Murray writes and speaks regularly
on the challenges facing the healthcare industry. He is
editor of Health IQ, a publication focused on the value
of information in advancing evidence-based healthcare,
and also serves on the editorial advisory board of
Pharmaceutical Executive. Murray holds a Master of
Commerce degree from the University of Auckland
in New Zealand, and received an M.B.A. degree with
distinction from Harvard University.

54 | 15+ Years of Biosimilar Experience in Europe: Omnitrope® Case Study

About the Institute
The IQVIA Institute for Human Data Science • Understanding the future role for biopharmaceuticals
contributes to the advancement of human health in human health, market dynamics, and implications
globally through timely research, insightful analysis and for manufacturers, public and private payers,
scientific expertise applied to granular non-identified providers, patients, pharmacists and distributors.
patient-level data.
• Researching the role of technology in health system
Fulfilling an essential need within healthcare, the products, processes and delivery systems and the
Institute delivers objective, relevant insights and business and policy systems that drive innovation.
research that accelerate understanding and innovation
Guiding principles
critical to sound decision making and improved
The Institute operates from a set of guiding principles:
human outcomes. With access to IQVIA’s institutional
knowledge, advanced analytics, technology and • Healthcare solutions of the future require fact based
unparalleled data the Institute works in tandem with a scientific evidence, expert analysis of information,
broad set of healthcare stakeholders to drive a research technology, ingenuity and a focus on individuals.
agenda focused on Human Data Science including
• Rigorous analysis must be applied to vast amounts of
government agencies, academic institutions, the life
timely, high quality and relevant data to provide value
sciences industry, and payers.
and move healthcare forward.
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• Collaboration across all stakeholders in the
The research agenda for the Institute centers on
public and private sectors is critical to advancing
five areas considered vital to contributing to the
healthcare solutions.
advancement of human health globally:
• Insights gained from information and analysis should
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be made widely available to healthcare stakeholders.
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be based on the use of non-identified patient information
• Addressing opportunities to improve clinical
and provider information will be aggregated.
development productivity focused on innovative
treatments that advance healthcare globally. • Information will be used responsibly to advance
research, inform discourse, achieve better healthcare
• Optimizing the performance of health systems by
and improve the health of all people.
focusing on patient centricity, precision medicine
and better understanding disease causes, treatment
consequences and measures to improve quality and
cost of healthcare delivered to patients.

iqviainstitute.org | 55
The IQVIA Institute for Human Data Science
is committed to using human data science to
provide timely, fact-based perspectives on the
dynamics of health systems and human health
around the world. The cover artwork is a visual
representation of this mission. Using algorithms
and data from the report itself, the final image
presents a new perspective on the complexity,
beauty and mathematics of human data science
and the insights within the pages.

The algorithmic art on the cover of this report was

generated from data that captures the spending
on biologics in Europe from 2005 to 2021 and the
uptake of biosimilars by volume across multiple
therapy areas in that time period.

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