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2015: The Pathway to Biosimilars, LMG Life Sciences

December 24, 2015

In 2015 there were many important developments in the biosimilar industry. The FDA approved its first biosimilar application, Zarxio, a biosimilar of Amgen’s Neupogen, after which the Federal Circuit affirmed that the notification procedures described by the biologics license application, or “patent dance,” are not mandatory. States have been increasingly regulating the use of biosimilars, before any drugs have entered the market. These developments have helped clarify the regulatory path for biosimilar manufacturers and indicate the potential for a promising future for the growing biosimilar market.

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