Amgen, Novartis biosimilars news

The U.S. Court of Appeals for the Federal Circuit (CAFC) issued a ruling and extended an injunction that will delay until Sept. 2 the launch of Zarxio filgrastim-sndz from Novartis’ Sandoz Inc. generics unit. FDA approved Zarxio -- a biosimilar of Neupogen filgrastim, a recombinant methionyl human G-CSF from Amgen -- on March 6.

The CAFC said 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, overturning a district court judgment. Sandoz had given Amgen notice of its intent to market Zarxio before FDA approved the drug. The CAFC held that giving notice after FDA approval, once the scope of approval and approximate launch timing are known, will allow a reference product sponsor “to effectively determine whether, and on which patents, to seek a preliminary injunction from the court.” ...