BioCentury
ARTICLE | Company News

Amgen, Novartis biosimilars news

April 6, 2015 7:00 AM UTC

Novartis’ Sandoz Inc. generics unit filed an opposition brief to Amgen’s motion seeking a preliminary injunction pending appeal that would prevent Sandoz from launching Zarxio filgrastim-sndz. Amgen subsequently filed a reply to the opposition brief. The biosimilar of Amgen’s Neupogen filgrastim is the first approved biosimilar product in the U.S. Sandoz filed the brief in the U.S. District Court for the Northern District of California. Last month, Amgen filed an appeal to the U.S. Court of Appeals for the Federal Circuit (CAFC) after the district court denied Amgen’s motion for a preliminary injunction seeking to prevent a Zarxio launch (see BioCentury, March 23 & March 30).

In its brief, Sandoz said Amgen’s motion fails to meet standards for granting a preliminary injunction and that no oral argument should be needed to deny the motion because Amgen “simply repeats arguments that this Court already rejected after a full briefing and argument.” In its reply, Amgen says that Sandoz’s opposition “directs its arguments to an injunction that would span the entire 410-day period under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), rather than they very limited relief that Amgen is actually seeking” for an injunction only while CAFC considers Amgen’s appeal. ...