Amgen sues Hospira over Epogen biosimilar BLA

Amgen Inc. (NASDAQ:AMGN) filed suit against the Hospira Inc. subsidiary of Pfizer Inc. (NYSE:PFE) in an attempt to delay the approval and launch of Retacrit, a biosimilar of anemia drugs Epogen epoetin alfa from Amgen and Procrit epoetin alfa from the Janssen Biotech unit of Johnson & Johnson (NYSE:JNJ). The erythropoietin receptor agonist is under FDA review; the 10-month user fee goal for an FDA regulatory decision is Oct. 16.

The suit, filed last week in the U.S. District Court for the District of Delaware, alleges Hospira did not comply with the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Amgen also alleges infringement of U.S. Patents Nos. 5,856,298 and 5,756,349 covering Epogen. ...