Amgen Inc, Novartis biosimilars news

Amgen filed an appeal in the U.S. Court of Appeals for the Federal Circuit (CAFC) of a district court ruling denying the company’s motions to prevent Novartis’ Sandoz Inc. generics unit from launching Zarxio filgrastim-sndz, a biosimilar of Amgen’s Neupogen filgrastim. Amgen also filed a motion in the U.S. District Court for the Northern District of California seeking a preliminary injunction that would delay Sandoz’s launch of Zarxio until the CAFC resolves Amgen’s appeal. The district court hearing is scheduled for April 30, but both companies have requested a hearing date as early as April 2. If the motion is denied, Amgen said it will file a motion for an injunction pending appeal with the CAFC (see BioCentury, March 23).

Additionally, FDA denied Amgen’s Citizen’s Petition requesting FDA to require biosimilar applications to include certifications that applicants will timely comply with the Biologics Price Competition and Innovation Act of 2009 (BPCIA) “by providing the reference product sponsor with a copy of the biosimilar application and information that describes the process(es) used to manufacture the biosimilar product that is the subject of that application.” Amgen filed the Citizen’s Petition in October, alleging that Sandoz refused to follow the patent resolution protocol laid out by the BPCIA (see BioCentury, Nov. 3, 2014 & Nov. 10, 2014). ...