biosimilar current market and its future scope

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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