US Court of Appeals rejects Amgen's complaints over Sandoz's biosimilar launch

The US Court of Appeals for the Federal Circuit has rejected arguments by US biotech major Amgen (Nasdaq: AMGN) that Novartis (VTX: NOVN) failed to properly follow regulations when it sought to launch Zarxio (filgrastim-sndz).

Zarxio is Novartis’ generic subsidiary Sandoz biosimilar of Amgen’s neutropenia treatment Neupogen (filgrastim). Under federal law governing biologics, Sandoz must wait six months after approval for Zarxio from the US Food and Drug Administration before it can begin marketing the therapy. The FDA approved Zarxio in March.

Amgen won an injunction blocking the launch of Zarxio in May, arguing that Novartis had not followed some of the required notification steps. The appeals court sided with a lower court judge who had agreed with Novartis’ stance that these were not mandatory steps. The appeals panel remanded the case back to the trial judge to decide whether Zarxio infringes an Amgen patent for Neupogen.