Amgen Stops Sales of Zarxio®, For Now
May 6, 2015
On May 5, 2015, the Federal Circuit granted Amgen a temporary reprieve in its fight with Sandoz regarding whether Sandoz may sell Zarxio®, its FDA-approved biosimilar to Amgen’s Neupogen® product, before completion of the pre-litigation procedures outlined in the Biologics Price Competition and Innovation Act (BPCIA). In Amgen Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. May 5, 2015), the Federal Circuit granted Amgen’s motion for a temporary injunction pending a June 3, 2015, hearing on Amgen’s motion for a preliminary injunction. The Federal Circuit’s temporary injunction is “effective immediately,” and the parties have 14 days to brief the court on the appropriate amount of the bond Amgen will need to post. For Amgen, the Federal Circuit’s decision comes just in time, as Sandoz had indicated it would launch Zarxio® on or around May 11, 2015. Amgen’s “Emergency Motion” for an injunction pending appeal, Sandoz’s opposition, and Amgen’s reply, can be found below:
Tags
Biologics Price Competition and Innovation Act (BPCIA), Food and Drug Administration (FDA), United States Court of Appeals for the Federal Circuit (CAFC)
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