Amgen, Novartis biosimilars news
The U.S. Court of Appeals for the Federal Circuit (CAFC) heard oral arguments from Amgen and Novartis’ Sandoz Inc. generics unit in a case that could set a precedent for the biosimilar application process in the U.S. Sandoz’s Zarxio filgrastim-sndz, a biosimilar of Amgen’s Neupogen filgrastim methionyl human G-CSF, is the first biosimilar product approved in the U.S.
Amgen is seeking to overturn a district court ruling in favor of Sandoz’s interpretation of the patent resolution protocol in the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Amgen’s initial suit in the U.S. District Court for the Northern District of California alleged Sandoz violated the BPCIA when it refused to provide its BLA and manufacturing information to Amgen and prematurely gave Amgen its 180-day notice of intent to market Zarxio prior to FDA’s approval of the product. ...