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On May 5, 2015, the Federal Circuit issued an Order preventing Sandoz from launching its biosimilar drug, Zarxio® in the United States, pending a decision on Amgen’s motion for a preliminary injunction. Despite being FDA approved on March 6, 2015, Zarxio® will now not enter the market until later this year, at the earliest.

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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 Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

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