US Appeals Court pauses marketing of biosimilar Neupogen from Sandoz

The US Court of Appeals for the Federal Circuit issued an injunction this week blocking Swiss pharma major Novartis’ (NOVN: VX) US generics subsidiary Sandoz Inc from selling a biosimilar version of Amgen’s (Nasdaq: AMGN) drug Neupogen (filgrastim) until the court resolves a pending appeal over the medication's release, reported TheRecorder.

Sandoz received approval from the US Food and Drug Administration earlier this year for its biosimilar drug Zarxio (filgrastim-sndz) for all indications included in the label of the reference product, Amgen's Neupogen, which generated $1.2 billion in sales last year (The Pharma Letter March 6). Sandoz is the first company to receive approval of a biosimilar in the USA through the new FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act.

Sandoz has agreed to refrain from launching its Zarxio product until the earlier of May 11, 2015 or a decision by the Federal Circuit on Amgen's application for an injunction pending appeal, the court’s filing confirmed.