FDA staffers back approval of Novartis' biosimilar of Amgen's Neupogen

In briefing papers ahead of an advisory committee meeting, agency staff at the US Food and Drug Administration are recommending clearance of a biosimilar version of Amgen's (Nasdaq: AMGN) Neupogen (filgrastim), manufactured by Swiss drug major Novartis (NOVN: VX).

In documents released before the advisory meeting on January 7, the staffers said there was "no clinically meaningful differences" between Neupogen and Novartis' biosimilar and that they back approval of the biosimilar in all five indications currently approved for Neupogen.

The Sandoz generics unit of Novartis released pivotal Phase III results in December, showing that the biosimilar demonstrated ‘similarity’ to Neupogen in severe neutropenia in breast cancer.