Name: Ridus Haroon

Roll no: 21-10884

Course: Commercialization of biotechnology
Course code: BIOT305
Section: A
Instructor: Z. Mehmood

Assignment: Biotechnology products(any 2)

Date of Submission: 12-10-19

 Biotechnology products

(Any two)

1. HUMIRA

Drug revenue: $12.5 billion

Drugmaker: AbbVie

AbbVie’s stock increased more than 2 percent recently because of the

company’s remarkably performing drug, humira, during the third

quarter of the year 2014. It was ranked no. 1 as the top best selling

biotech drugs in 2014.

RANK DRUG TREATS DRUGMAKER DRUG TOTAL

REVENUE REVENUE
1 Humira Rheumatoid AbbVie $12.5 $20 billion
arthritis billion
Plaque psoriasis
Crohn's disease
Pediatric Crohn's
disease
Ulcerative colitis
Psoriatic arthritis
Ankylosing
spondylitis
Polyarticular
juvenile idiopathic
arthritis
Launch:

Adalimumab is a subcutaneously administered biological disease modifier for the

treatment of rheumatoid arthritis and other chronic debilitating diseases mediated
by tumor necrosis factor. It was originally launched by Abbvie in the U.S. and
approved in 2002 by the FDA. This drug is frequently known as Humira. It is
produced by recombinant DNA technology using a mammalian cell expression
system. This drug is available in a prefilled syringe form and convenient pen form
for subcutaneous self-administered doses

Composition:

HUMIRA (adalimumab) is a recombinant human IgG1 monoclonal

antibody specific for human tumor necrosis factor (TNF). HUMIRA

was created using phage display technology resulting in an

antibody with human derived heavy and light chain variable

regions and human IgG1:k constant regions. Adalimumab is

produced by recombinant DNA technology in a mammalian cell

expression system and is purified by a process that includes

specific viral inactivation and removal steps. It consists of

1330 amino acids and has a molecular weight of approximately

148 kilodaltons.

HUMIRA is supplied as a sterile, preservative-free solution of

adalimumab for subcutaneous administration. The drug product is

supplied as either a single-use, prefilled pen (HUMIRA Pen), as a

single-use, 1 mL prefilled glass syringe, or as a single-use

institutional use vial. Enclosed within the pen is a single-use, 1 mL

prefilled glass syringe. The solution of HUMIRA is clear and

colorless, with a pH of about 5.2.

Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8

mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains

adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate
dihydrate (1.22 mg), mannitol (9.6 mg),monobasic sodium phosphate dihydrate
(0.69 mg), polysorbate 80

(0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and

Water for Injection, USP. Sodium hydroxide is added as necessary

to adjust pH.

Indications:

Rheumatoid Arthritis

HUMIRA is indicated for reducing signs and symptoms, inducing major

clinical response, inhibiting the progression of structural damage, and

improving physical function in adult patients with moderately to

severely active rheumatoid arthritis. HUMIRA can be used alone or in

combination with methotrexate or other non-biologic disease-modifying

anti-rheumatic drugs (DMARDs).

Juvenile Idiopathic Arthritis

HUMIRA is indicated for reducing signs and symptoms of moderately to

severely active polyarticular juvenile idiopathic arthritis in patients 2

years of age and older. HUMIRA can be used alone or in combination

with methotrexate.

Psoriatic Arthritis

HUMIRA is indicated for reducing signs and symptoms, inhibiting the progression
of structural damage, and improving physical function in adult patients with active
psoriatic arthritis. HUMIRA can be used alone or in combination with non-
biologic DMARDs.

Ankylosing Spondylitis

HUMIRA is indicated for reducing signs and symptoms in adult patients

with active ankylosing spondylitis.

Adult Crohn’s Disease

HUMIRA is indicated for reducing signs and symptoms and inducing and

maintaining clinical remission in adult patients with moderately to

severely active Crohn's diseasewho have had an inadequate response to

conventional therapy. HUMIRA is indicated for reducing signs and

symptoms and inducing clinical remission in these patients if they have

also lost response to or are intolerant to infliximab.

Pediatric Crohn’s Disease

HUMIRA is indicated for reducing signs and symptoms and inducing and

maintaining clinical remission in pediatric patients 6 years of age and

older with moderately to severely active Crohn's disease who have had

an inadequate response to corticosteroids or immunomodulators such

as azathioprine, 6-mercaptopurine, or methotrexate.

Ulcerative Colitis

HUMIRA is indicated for inducing and sustaining clinical remission in

adult patients with moderately to severely active ulcerative colitis who have had an
inadequate response to immunosuppressants such as corticosteroids, azathioprine
or 6-mercaptopurine (6-MP).

Plaque Psoriasis

HUMIRA is indicated for the treatment of adult patients with moderate

to severe chronic plaque psoriasis who are candidates for systemic

therapy or phototherapy, and when other systemic therapies are

medically less appropriate.

Hidradenitis Suppurativa

HUMIRA is indicated for the treatment of moderate to

severe hidradenitis suppurativa.

Uveitis

HUMIRA is indicated for the treatment of non-infectious

intermediate, posterior, and panuveitis in adults and pediatric patients 2

years of age and older.

2. BIOTECH SOYBEAN

Composition:

A genetically modified soybean is a soybean (Glycine max) that

has had DNA introduced into it using genetic engineering

techniques.

Maker:
In 1996 the first genetically modified soybean was

introduced to the U.S. market, by Monsanto.

Soybean is the oil crop of greatest economic relevance in the

world. Its beans contain proportionally more essential amino acids

than meat, thus making it one of the most important food crops

today.

Importance of this GMO:

Processed soybeans are important ingredients in many

food products.

Types:

Herbicide tolerant soybean

Herbicide tolerant soybean varieties contain a gene that provides

resistance to one of two broad spectrum herbicides.

This modified soybean provides better weed control and reduces

crop injury. It also improves farm efficiency by optimizing yield,

using arable land more efficiently, saving time for the farmer, and

increasing the flexibility of crop rotation. It also encourages

adoption of no-till farming - an important part of soil conservation

practice. These varieties are the same as other soybeans in

nutrition, composition, and in the way they are processed into food

and feed.

Insect resistant soybean

This biotech soybean exhibits resistance to lepidopteran pests

through the production of Cry1Ac protein. Insect resistant soybean

was developed to reduce or replace high insecticide applications

and at the same time maintain soybean yield potential.

Oleic acid soybean

This modified soybean contains high levels of oleic acid, a

monounsaturated fat. According to health nutritionists,

monounsaturated fats are considered “good” fats compared with

saturated fats found in beef, pork, cheese, and other dairy

products.

Oil processed from these varieties is similar to that of peanut and

olive oils. Conventional soybeans have an oleic acid content of

24%. These new varieties have an oleic acid content that exceeds 80% .