Amgen Inc. is seeking a preliminary injunction against Sandoz, a subsidiary of Novartis AG, over its application for the biosimilar version of Amgen’s blockbuster drug, Neupogen, for the treatment of neutropenia in cancer patients.
In January of this year, the FDA review committee announced it found “no clinically meaningful differences” between Amgen's Neupogen and the biosimilar version from Sandoz.
With FDA approval potentially only a month away, a decision regarding Amgen's request -- part of a patent suit filed last November -- is expected to be announced by March 8th.
With the launch of a biosimilar imminent, analysts predict that Neupogen could lose its blockbuster status by 2016.
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