biosimilar current market and its future scope
TRANSCRIPT
Biosimilar current market and its future scope
By Gopal Agrawal
Department of Biotechnology
NIPER-MOHALI
CONTENT • What is Biosimilar???
• Biosimilars approval requirement
• Biosimilar Versus Generics
• Indian company in Biosimilar
• World Company in biosimilar
• Recent Advances in Biosimilars
• Current Market of Biosimilars
• Future Scope of Biosimilars
• References
• Author information
highly similar to an already FDA-approved biological product
have been shown to have no clinically meaningful differences
Mechanism of action
• Route of administration
• Dosage form
• Strength
• As the reference product
• *****Biosimilars can only be approved for the conditions of use and indication for which the reference of the product is approved.
• The PHS Act requires that a 351(k) application include, among other things,information demonstrating biosimilarity based upon data derived from:
• Analytical studies demonstrating that the biological product is “highly similar” tothe reference product notwithstanding minor differences in clinically inactivecomponents;
• Animal studies(including the assessment of toxicity); and
• A clinical study or studies(including the assessment of immunogenicity andpharmacokinetics (PK) or pharmacodynamics (PD)) that are sufficient todemonstrate safety, purity, and potency in 1 or more appropriate conditions of usefor which the reference product is licensed and for which licensure is sought for thebiosimilar product.
• FDA may determine, in its discretion, that an element described above isunnecessary in a 351(k) application.
• Comparative human PK (and PD) data
• PK and/or PD is generally considered the most sensitive clinical study/assay in which to assess for differences, should they exist
Support a demonstration of biosimilarity with the assumption that similar exposure (and pharmacodynamic response) provides similar efficacy and safety (i.e., an exposure-response relationship exists)
Clinical PK data generally will be expected; PD data desirable (case by case consideration)
• Study Design
Study population
PD endpoint
Route of administration
• Data analysis plan
Acceptance range
Choice of primary endpoints
Others
Generics vs Biosimilars
Reference: Amgen.com
• On the basis of applications the biosimilars market is segmented into oncology, blood disorders, growth hormonal deficiency, chronic and autoimmune disorders, and other applications (female infertility, hypoglycemia, myocardial infarction, postmenopausal osteoporosis, and chronic kidney failure).
Oncology accounts for the largest share of the global market, owing to the launch of new biosimilars, namely, Remsima (monoclonal antibody) in Europe, and Neutroval and tbo-filgrastim in the U.S.
• The high growth in this segment can be attributed to the rising incidences of autoimmune disorders such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriatic arthritis, Type 1 diabetes, and psoriasis.
• Geography, the biosimilars market is segmented into North America, Europe, Asia-Pacific, and the RoW (Latin America, Middle East, and Africa).
In 2015, Europe is expected to dominate the global market; growth in this market can be attributed to the growing pressure to curtail healthcare costs, patent expiry of biologic products, launch of new biosimilar products, rising incidences of chronic disorders (such as cancer, diabetes, and rheumatoid arthritis), and emergence of new market participants in this region.
India Biosimilar market
India Biosimilar market
Sandoz International GmbH (Germany)
Hospira, Inc. (U.S.)
Teva Pharmaceutical Industries Ltd. (Israel)
Dr. Reddy’s Laboratories (India)
Biocon Limited (India)
Mylan, Inc. (U.S.)
Amgen (U.S.)
Celltrion Inc. (South Korea)
Roche Diagnostics (Switzerland)
Merck KGaA (Germany).
• Europe
Currently, there are three biosimilar versions of G-CSF available in the European market, namely Ratiograstim/Tevagrastim/Biograstim, Zarzio/Filgrastim Hexal and Nivestim/Pliva/Mayne filgrastim
the recombinant nonglycosylatedprotein segment is expected to account for the largest share of the biosimilarsmarket in 2015
the global biosimilars market is dominated by Europethe Asia-Pacific
region is likely to witness the highest growth rate during the forecast period
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