March 6, 2015 was a turning point for the emerging U.S. biosimilars market. The U.S. Food and Drug Administration (FDA) approved Sandoz’s application to market Zarxio®, the first biosimilar drug in the U.S. Zarxio® (approved as “filgrastim-sndz”) is a biosimilar of Amgen’s Neupogen®, a drug with 2013 sales of $1.4bn. Zarxio® is currently on the market in Europe (as Zarzio®), and is now approved in the U.S. as a 0.5 ml and a 0.8 ml injectable for all five of the indications on the Neupogen® label, including the treatment of patients with various cancers, and the treatment of patients with various forms of neutropenia (white blood cell disorders).
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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. She has a B.Sc. honors degree in Human Genetics.
