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The U.S. Biosimilars Market is Heating Up: Guidance from the Federal Circuit is Expected Late Spring

by Robert S. Schwartz, Ph.D.; Corinne E. Atton
April 6, 2015

It has been five years to the month since the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law, and March 2015 was the busiest month to date for the emerging U.S. biosimilars market. Currently worth approximately $1 billion a year worldwide, reports predict that this market will be worth at least $20 billion a year by 2020. This provides a strong incentive for companies like Sandoz, Celltrion, Hospira, Eli Lilly, Teva, Apotex, Accord, Ratiopharm, and others who currently market the 19 biosimilar drugs that are on sale in Europe, to seek approval in the lucrative U.S. market.

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Bob Schwartz has extensive experience litigating biotechnology and pharmaceutical patents, including those relating to antibodies, protein biochemistry, molecular biology, genomics and proteomics. Bob has a B.S. in Biology and a Ph.D. in Biochemistry. As a Principal Investigator of grant-funded research he published more than 40 articles in peer-reviewed publications and 7 book chapters.
Corinne Atton has experience litigating cases concerning a wide range of pharmaceuticals and biotechnology, including DNA sequences, DNA sequencing technologies, recombinant polypeptides, enzyme inhibitors, and antidiabetic drugs. Corinne has a B.Sc. honors degree in Human Genetics.

 

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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