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Amgen sues Sandoz over filgrastim biosimilar BLA

October 31, 2014 2:37 AM UTC

In the first lawsuit filed by an originator company over a biosimilars application, Amgen Inc. (NASDAQ:AMGN) alleged that the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) has unlawfully refused to follow the patent resolution protocol laid out by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

The suit, filed in the U.S. District Court for the Northern District of California, concerns Sandoz's application to market a biosimilar version of Amgen's Neupogen filgrastim G-CSF, a recombinant methionyl human granulocyte colony-stimulating factor. ...