FDA approves Zarxio, first biosimilar in U.S.

FDA approved Zarxio filgrastim-sndz from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) for the same indications as its reference product, Neupogen filgrastim methionyl human G-CSF from Amgen Inc. (NASDAQ:AMGN). The agency said filgrastim-sndz is a "placeholder nonproprietary name," noting that it is not reflective of the agency's biosimilar naming policy. FDA intends to issue draft guidance on biosimilar naming, though it has not disclosed a timeline.

Sandoz said it will not discuss Zarxio's price until its launch. Zarxio's launch date depends on pending litigation between Sandoz and Amgen, which has alleged that Sandoz refused to comply with the Biologics Price Competition and Innovation Act of 2009 when it filed its BLA for Zarxio. The U.S. District Court for the Northern District of California plans to hear the case on March 13. ...