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Biosimilars Overview 18012007 v2
Biosimilars Overview 18012007 v2
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
Contents
– Background
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– Geographic highlights
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– Business Options
• Concluding Comments
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
Biologics - Background
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Next • The innovation gap for big pharma is filled by biologics (# of NME
approvals for biotech products have exceeded that of big pharma2 )
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• >400 biologics in development constituting ~19% of all developments
Ref:: 1IMS Global Insights 2005; ET Dec 30 2006; 2E&Y Biotech Industry Report 2006; 3
PhRMA Report 2006, IMS-New Markets & Products in 2005; Stratycon Estimates © Stratycon Business Solutions Pvt.. Ltd. 2005-07
Biologics constituted ~9.4% of the total
biopharmaceutical market
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US, $32.80
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EU, $12.18
ROW, $4.43
• US is the largest market for biologics with >60% of global biotherapeutic sales, ROW constitutes ~8%
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• Current market for biologics ~$ 33 bio.
• Growing at >17% YoY
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• EPO constitute major proportion of sales
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Ref:: IMS Industry in Figures 2005; JETRO, Japanese Patent Office Survey, Stratycon 5
Estimates © Stratycon Business Solutions Pvt.. Ltd. 2005-07
But the growth of biotech has continuously
outpaced that of pharmaceuticals
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30%
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25%
YoY Growth in %
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20%
15%
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10%
5%
0%
2000 2001 2002 2003 2004 2005
Pharmaceuticals Biologics
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# of Biotech Products with >$1bio sales
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25 24
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20
20
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15
11
10
7
6
5
3 3
0
2000 2001 2002 2003 2004 2005 2006
Ref:: IMS Outlook 2005 & Beyond; Product & Company Research by Stratycon 7
© Stratycon Business Solutions Pvt.. Ltd. 2005-07
..also the number of NBEs approved by FDA till
2005
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25
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# of NBEs approved by US FDA
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20
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15
15
13
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Last 12
10
5 4
2
0
2001 2002 2003 2004 2005 2006 2007 till Nov
30
70 66.45
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60
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Biologics Market in $bio.
50
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40
30
24.92
20
11.08
9.55
10
0
US EU Japan ROW
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Products
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Erythropoietin, TNF, insulin analogs and cancer antibodies are
leading biologic categories (excluding vaccines)
Neulasta/Neupogen G-CSF from Amgen is the leading biologic with
2005 global sales of $3.5 bio.
Top 10 biologics constitute 49.5% of total biologics market
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
Erythropoietin is the leading class of biologic
constituting ~22% of biologic market (excl. vaccines)
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12.0 Erythropoietins
10.9
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Previous TNF
10.0
Insulin & analogs
2005 Global Sales $ bio.
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Next Cancer Antibodies
8.0 7.6
7.2 Interferon Beta
6.8
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Last G-CSF
6.0
Human Growth Hormone
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
7 of top 10 products have annual global sales of > $ 2
bio. (2005)
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4.0
Neulasta/NEUPOGEN
3.5
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Previous 3.5 3.33 3.32 3.27 MabThera/Rituxan
3.0 Procrit/Eprex
2005 Global Sales $ bio.
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2.57 2.54 2.46 Aranesp
2.5
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2.0 1.81
1.72
Remicade
1.54
1.5
Epogen
1.0 NeoRecormon,Epogin
Herceptin
0.5
Avonex
0.0
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
Leading Biotech Products
Product Compound Company 2005 ww Sales Growth (Y0Y) %
($ bio.)*
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Previous MABTHERA/ RITUXAN rituximab Roche/Genentech 3.33 22.0%
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ARANESP darbepoietin alfa Amgen 3.27 32.0%
Neulasta/Neupogen
3.5 MabThera/Rituxan
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Procrit/Eprex Aranesp
2005 Global Sales in $ bio.
3.0
2.0
Last
Last NeoRecormon,Epogin
Herceptin
1.5 Avonex
1.0
0.5
0.0
-10% 0% 10% 20% 30% 40% 50% 60%
YoY Growth
• The Strongest growth was observed for Avastin - bevacizumab (+141%), Humira (+64%) and Herceptin (+48%)
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
Home
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Pipeline of Biologics
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
Monoclonal antibodies, gene therapy are constitute
major proportion of biologic pipeline apart from
vaccines
# of Biologic in Development by Category
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62
Others
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Previous 8
Interleukins
9
Immune based therapy
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Next Growth Factors 16
Interferons 18
Antisense 20
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Cellular therapy 21
Recombinant Hormones/Proteins 43
Gene Therapy 46
Vaccines 62
mAbs
160
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Other
4
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Growth Disorders
6
Eye Conditions
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Next Skin Disorders
7
Blood Disorders 10
Respiratory Disorders 13
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Last Digestive 14
Diabetes/Related 15
Neurologic Disorders 17
Cardiovascular 22
AIDS/HIV Related 22
Autoimmune 44
Infectious Diseases
50
Cancer/Related
210
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Biosimilars
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
Biosimilars - Background
Ref:: The Future of Biogenerics- PharmaVoice – May 2005; Chemical & Engineering News - 19
June 6, 2005; F&S Articles, Stratycon Analysis © Stratycon Business Solutions Pvt.. Ltd. 2005-07
Selected biologics with expired patent
Product Compound Company Expired
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Novolin Human Insulin NovoNordisk 2005
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Last Epogen, Procrit EPO-α Amgen/J&J/Sankyo 2004
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
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Biosimilars - Regulatory
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
EU has defined regulatory requirements
for biosimilars
• The Committee for Medicinal Products for Human Use (CHMP) issues specific
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– Comparability studies are required to substantiate evidence for safety, efficacy and quality
– Advised to approach EMEA for detailed case by case basis guidance on studies required to
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be conducted
– Product-class specific guidance documents on pre-clinical and clinical studies to be
conducted for the development of biosimilars will be progressively available
• Omnitrope is the first biosimilar to be approved in EU, which was earlier approved
in Australia by TGA. Biopartner’s Valtropin is approved and α interferon is under
review
• Note: EU has constituted 10 year data exclusivity period for all pharmaceutical innovators.
(this prevents a patent challenger to use innovators safety & efficacy data)
Ref: FDA
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
US - Some products under NDA may be approved
without new ‘follow on biologics’ legislation!
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Insulin Interferons
Calcitonin EPO
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PTH mAb
Imigucerase Enzymes
Aprotinin
Hyaluronidase
Ref: FDA
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
Japan – PDMA – Office of biologics
evaluates generic biologics
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Last
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Competitive Intensity
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
Foreseeing Competitive Intensity
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• How complex is the manufacturing process?
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
Biosimilars – Evaluating Probable
Competitive Intensity
Size of bubble: Innovator Brand Sales -2005 ($ bio.)
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7
Neupogen
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Retuxan
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5
Procrit/Eprex
Ease of Mnf. Score
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Enbrel
4
Humulin
3
Avastin
2
Genotropin
1
1 2 3 4 5 6 7
Reg. Simplicity
Portfolio Development Path (considering market size)
BioGeneriX D D 2
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GeneMedix D M D D 4
Dragon M 1
Biocon D M M D D D D 7
Scino Pharma D D D D D 5
SciGen M M M D D 5
Wockhardt M D M D 4
DRL D M D 3
Shanta Biotech M D M M D 5
Total 11 9 6 7 9 3 6 52
Total (M) 5 5 5 4 4 1 0 24
Biosimilars
Biosimilars Regulatory
Regulatory
Process
Process in
in Question
Question
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Next Less More
Time to Time to
Market Market
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Last Higher
Higher Price Lower Price Lower Competitive
Competitive
Differential Differential Intensity
Intensity
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CONSTRAINTS DRIVERS
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• Regulatory • Biologics segment size & growth
– No clear cut regulatory mechanism in – Biologics performance exceeds that
US, Japan of overall market
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• Technological – Biologics worth $18 bio. Will go off
patent by 2011
– Manufacturing complexity
–
• Increasing pressure to reduce
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healthcare expenditure
– Higher cost to prove comparability
– Evolving regulatory mechanisms to
• Market Factors recognise biosimilars (EU, Australia)
– Next generation biologics • Semi/unregulated markets as launch
– Limited discounting ability pad
(discounting in the range 25% to
30%) • Generic majors like Teva, Maine,
Pliva developing biosimilar
– Authorised generics/price cuts
capabilities through partnerships as
– Gaining acceptance by clinicians well
(brand based competition)
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
Business Options – Step by step
approach?
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Japan!
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Next US
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EU
Unregulated Markets
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
Analyzing business options
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Market yourself?
Authorized
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Previous Generics?
Selective partnering?
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Have/ Can build
Complete partnering?
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
Comments
Home • Biologics approved through NDA and easy to manufacture could be the
first targets for generic manufacturers
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Previous • Semi/unregulated markets could act as launch pad for biosimilars and
could be beneficial in accelerated approvals in regulated markets (once
the guidelines are in place)
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• Big generic companies like Teva, Sandoz, Pliva have significant focus
on biosimilars and have access to market and marketing resources
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• Medium size/ biotechs from developing world are increasingly following
collaborative models to accelerate commercialization of their biologics
• Biologic innovators will move forward with the next-generation
biologics trying to make up for revenue loss due to biosimilars
– This is facilitated by biotech innovators bridging the innovation gap of big
pharmaceuticals
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
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Back-up
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
Global Pharmaceutical Market Sales
Global Pharmaceuticals Sales 2005
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2005
North America Europe Japan Asia, Africa and Australia Latin America
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25 54%
53.3%
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52%
20
Generic Sales in US - $ bio
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50.5%
50%
% Generic Rx
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48.1% 48%
47.4%
10 46.6%
46.5%
46%
5
44%
11 13 14.3 16 18 22
0 42%
2000 2001 2002 2003 2004 2005
Ref:: GPhA 38
© Stratycon Business Solutions Pvt.. Ltd. 2005-07
Leading products Next 10 (rank 10 to 20)
1.4 Humira
Avastin
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1.3
Rebif
Neupogen
2005 Global Sales in $ bio.
Lantus
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Next 1.2 Humalog
Pegasys
1.1 Synagis
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1.0 Betaferon
Humulin
0.9
0.8
0.7
0.6
-20% 0% 20% 40% 60% 80% 100% 120% 140% 160%
YoY Growth
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07
Analysis of approval pattern of biologics
by expression system & source (US)
Products by Expression System
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45
40 0 Natural Extract
35
# of Biologics
1
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30 8 26 culture
25 4 Yeast
20
10
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Next 15 2 Bacteria
10
13
5 11
None (Synthetic)
0 0
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NDA BLA
Products by Source
45
40
native DNA
35 2
# of Biologics
30
rDNA
25
21 41
20 Synthetic
15
10
5 11
0
NDA BLA
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Expression System
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© Stratycon Business Solutions Pvt.. Ltd. 2005-07