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Amgen v. Sandoz biosimilars litigation could impact the industry for years to come
October 12, 2015
By: Kristin Brooks
Managing Editor, Contract Pharma
With the FDA approval of the first biosimilar in the U.S., Novartis’ Zarxio (Amgen’s Neupogen), back in March, drug maker Amgen is now fighting to uphold its patent. On September 2, the Federal Circuit issued its decision denying request for a temporary restraining order in Amgen v. Sandoz, an important biosimilars litigation that could have an impact on the industry for years to come. Elaine Blais, partner in Goodwin Procter’s Litigation Department, opens our eyes to some of the legal nuances behind the biosimilar litigation, including commercial marketing issues, the “patent dance”, patent infringement disputes and the commercial launch of biosimilars, as well as “interchangeable” designation by FDA, which may be vital to the long-term market success of biosimilars in the U.S. –KB Contract Pharma: What are some of the main talking points in biosimilar litigation?
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