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Amgen, Novartis biosimilars news

November 3, 2014 8:00 AM UTC

Amgen filed a lawsuit in the U.S. District Court for the Northern District of California alleging that Novartis' Sandoz Inc. generics unit has not followed statutory requirements related to their submission of a BLA to FDA for a biosimilar version of Amgen's neutropenia drug Neupogen filgrastim G-CSF. Amgen argues that Sandoz did not provide Amgen with the BLA and manufacturing information within 20 days of FDA's acceptance for review, as required under the patent resolution protocol of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Amgen argued that Sandoz deprived Amgen of the opportunity to assess potential patent infringement claims related to U.S. Patent No. 6,162,427, which covers Neupogen.

Amgen is seeking compensatory and punitive damages, restitution for Sandoz's unlawful profits. Amgen is also seeking an injunction to prevent Sandoz from commercializing the biosimilar filgrastim until Amgen is "restored to the position it would have been had Defendants met their obligations under the BPCIA." Furthermore, Amgen is seeking an injunction to prevent Sandoz from advancing through FDA's approval process and judgment of infringement of the '427 patent. The suit demands a jury trial. ...