this slide cover in brief :
Biosimilars
current market of biosimilars
future market scope of Biosimilars
Biosimilars vs generics
Requirement for approval of biosimilars by USFDA
company producing Biosimilars
2. CONTENT
• What is Biosimilar???
• Biosimilars approval requirement
• BiosimilarVersus Generics
• Indian company in Biosimilar
• World Company in biosimilar
• Recent Advances in Biosimilars
• Current Market of Biosimilars
• Future Scope of Biosimilars
• References
• Author information
3. highly similar to an already
FDA-approved biological product
have been shown to
have no clinically meaningful differences
4.
5. 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.
6. • 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” to
the reference product notwithstanding minor differences in clinically inactive
components;
• Animal studies(including the assessment of toxicity); and
• A clinical study or studies(including the assessment of immunogenicity and
pharmacokinetics (PK) or pharmacodynamics (PD)) that are sufficient to
demonstrate safety, purity, and potency in 1 or more appropriate conditions of use
for which the reference product is licensed and for which licensure is sought for the
biosimilar product.
• FDA may determine, in its discretion, that an element described above is
unnecessary in a 351(k) application.
7. • 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)
8. • Study Design
Study population
PD endpoint
Route of administration
• Data analysis plan
Acceptance range
Choice of primary endpoints
Others
12. • 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.
13. • 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.
16. 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).
17. • 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
18. the recombinant nonglycosylated
protein segment is expected to account for the largest share of the biosimilars
market in 2015
the global biosimilars market is dominated by Europe
the Asia-Pacific
region is likely to witness the highest growth rate during the forecast period
