will indian generic pharma majors excel in biosimilars?

1. Will Indian generic
pharma majors excel in
biosimilars?
Reg no. 160617009
Presented by Ms. SHIKHA Y. SINGH
DEPARTMENT OF PHARMACEUTICS
MCOPS MANIPAL UNIVERSITY
ManipalCollegeofPharmaceuticalSciences(MCOPS)

2. Biosimilars
What is biosimilars?
• Almost an identical copy of an original biological product
• They are large molecules with high complexities
• They are prepared from engineered organisms
• Demonstrate safety, purity & potency
• Eg insulin produced from E.coli
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3. What happen after a patent get expire?
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When patent goes off/expires
Company produces generic version
Same API in different proportion with
unique manufacturing process

4. In case of biosimilars-
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When patent goes off/ expires
Its not easy for other companies to start
making a generic version
Patent holder to give his engineered
organism to anyone
Other companies will have to try to
replicate the engineered organism

5. Difficulties in producing biosimilars
1. Barrier to entry to a biosimilar is way higher
2. Cost of manufacture is non-trivial & not pennies
3. Only a handful of companies to produce a biosimilars
4. Process patents are much difficult to break for generic company
5. Often solo biosimilar company competing against the brand company
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6. • List of Indian companies
producing biosimilars:
1. Cipla
2. Lupin
3. Biocon Ltd
4. Cadila Healthcare
5. Intas Pharamceuticals Ltd
6. Dr Reddy's Laboratories Ltd
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Biosimilars industries in India

7. Conclusion
• Due to this complex base, biologics are not as easily copied as other drugs
therefore not much companies willing to put in that much effort & investment
• Indian market has witnessed nearly 20% annual growth for the year ending
November 2016 in the segment
• Biosimilars are the next big thing for Indian pharma
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