Amgen Wins Temporary Injunction Against Sandoz in Landmark Biosimilars Case


Amgen v. Sandoz, No. 15-1499 (Fed. Cir. May 5, 2015)

In a per curium Order today, the Federal Circuit granted Amgen’s Emergency Motion for an Injunction Pending Appeal, stalling, at least temporarily, Sandoz’s commercial launch of Zarxio, a biosimilar version of Amgen’s Neupogen (filgrastim). Zarxio is the first biosimilar product approved by FDA under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). FDA approved Zarxio on March 6, and Sandoz agreed not to commercially launch the product until May 11 or a Federal Circuit ruling in its favor.

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