CAFC ruling delays Zarxio launch until Sept. 2

The U.S. Court of Appeals for the Federal Circuit (CAFC) issued a ruling and extended an injunction that will delay until after Sept. 2 the launch of Zarxio filgrastim-sndz from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN). FDA approved Zarxio on March 6. It is a biosimilar of Neupogen filgrastim methionyl human G-CSF from Amgen Inc. (NASDAQ:AMGN).

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." ...