class work on Biosimilars

1. BY
HEMANT CHANDWANI
HEMANTH KODURI
VARUN REDDY THUMMALA
MBA-PM 07 BATCH

2.  A biopharmaceutical drug designed to have active properties similar
to one that has previously been licensed.
 Biosimilars are officially approved versions of original "innovator"
products, and can be manufactured when the original
product's patent expires.
 A Biosimilar is also known as “follow-on biologic” or “subsequent
entry biologic”.
 According to WHO: A biotherapeutic product which is similar in
terms of quality, safety and efficacy to an already licensed reference
biotherapeutic product.
 According to USFDA: A biosimilar is a biological product that is
highly similar to a US-licensed reference biological product
notwithstanding minor differences in clinically inactive components,
and for which there are no clinically meaningful differences between
the biological product and the reference product in terms of the safety,
purity, and potency of the product.

3.  Many of today’s important medications are biological products.
Biological products are made from living organisms. The material
they are made from can come from many sources, including
humans, animals and microorganisms such as bacteria or yeast.
Biological products are manufactured through biotechnology,
derived from natural sources or, in some cases, produced
synthetically.
 Biological products are among the medications used to treat
conditions such as rheumatoid arthritis, anemia, low white blood
cell counts, inflammatory bowel disease, skin conditions such as
psoriasis and various forms of cancer.

4. Sources of variation between manufacture of innovator Biopharmaceutical
and Biosimilars.
Source: Misra M, Biosimilars: current perspectives and future implications, Indian J
Pharmacol..,2012 Jan;44(1):12-4.
.

5. Biological Price Competition and Innovation Act, 2009 (BPCI)

6.  India is one of the leading contributors in the world biosimilar
market.
 Over 50 biopharmaceutical brands have got marketing approval.
 Potential to replicate success of Indian Generic Industry.
 Imported Innovators market is estimated around US$ 220 million.
 India has inherited advantages of:
Cost effective manufacturing
Highly skilled, reasonably priced workforce
Huge market.
 Key benefit→ Reduce cost by 20-25%
 Owing to affordability and easy accessibility, established good
reputation among healthcare professionals.

7. Trends:
 Target Markets : Domestic + Developed Market ( as Contract
Manufacturers).
 Stronger Acquisition Strategy : Capacity Building for
production.
 Aiming for Regulated Markets like US and EU also.
 Strong Response to Tap Opportunity from:
Biocon, Dr. Reddy’s Lab, Wockhardt, Cipla Pharmaceuticals.
 Partnerships.
 Merck Serono Enters Biosimilar Segment in Deal with Dr.
Reddy's, Jun 7, 2012, GEN News Highlights.
 Biosimilars collaboration at Amgen and Actavis, Generics and
Biosimilars Initiative Journal (GaBI Journal). 2014;3(3):155-
6.

8. Active
substance
Product
name
Launch date
in India
Company
Epoetin alfa Epofit/Eryki
ne
Aug 2005 Intas
Biopharma-
ceuticals
Darbopoetin
alfa
Cresp Aug 2010 Dr Reddy’s
Laboratories
Insulin
glargine
Basalog 2009 Biocon
Reteplase Mirel 2009 Reliance Life
Scienes
Rituximab Reditux Apr 2007 Dr Reddy’s
Laboratories

9. Regulatory framework in India:
 Similar biologics are regulated as per:-
• The Drugs and Cosmetics Act, 1940
• The Drugs Cosmetics Rules, 1945
• Rules for the manufacture, use, import, export & storage of
hazardous microorganisms/genetically engineered organisms or
cells, 1989. Notified under the Environment Protection Act.
 Apart from Central Drugs Standard Control Organization
(CDSCO), the office of Drug Controller General of India (DCGI)
two other competent authorities are involved in the approval
process:
1) Review Committee on Genetic Manipulation(RCGM)
2) Genetic Engineering Approval Committee (GEAC).

10.  Biotechnological medicines shall become an important part of
future healthcare landscape.
 With patent expiration of innovator products, biosimilars will
increasingly become available.
 Awareness of the deviations between biosimilars & innovator
products in terms of efficacy, safety & immunogenicity is
essential for proper prescription & safety of the patients.

11.  www.Biosimilars.com
 Biosimilars_Information for Consumers
 IMS Health.