Amgen moves to stall Zarxio launch again

Amgen Inc. (NASDAQ:AMGN) filed an emergency motion with the U.S. Court of Appeals for the Federal Circuit (CAFC) for an injunction to further delay the launch of Zarxio filgrastim-sndz from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) pending a potential en banc review of the case.

FDA approved Zarxio, a biosimilar of Amgen's Neupogen filgrastim methionyl human G-CSF, on March 6. In July, a CAFC ruling barred Sandoz from launching Zarxio until after Sept. 2; the court ruled that a BLA applicant planning to market a biosimilar may only give the required 180 days' notice to the sponsor of its reference drug after FDA has approved the biosimilar (see BioCentury Extra, July 21). ...