Amgen, Novartis biosimilars news

Amgen filed a motion in the U.S. District Court for the Northern District of California seeking a preliminary injunction that would prevent Novartis’ Sandoz Inc. generics unit from marketing Zarxio if FDA approves it as early as next month. Zarxio is a biosimilar of Amgen’s neutropenia drug Neupogen filgrastim recombinant methionyl human G-CSF.

On March 2, the court plans to hear Amgen’s motion for a preliminary injunction, as well as both parties’ motions for judgment on the pleadings. Zarxio’s earliest potential launch date is March 8. Last month, an FDA advisory committee voted 14-0 to recommend approval of Zarxio. Amgen contended that if the court rules in its favor, Zarxio’s launch should be delayed until both parties are “placed in the position they would be in had Sandoz complied with the BPCIA” (see BioCentury, Jan. 12). ...