FDA approves Nivestym, the second biosimilar to Neupogen cleared in the USA

On Friday, the US Food and Drug Administration approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim), for all eligible indications of the reference product and follows marketing authorization in Europe in 2010.

This approval for US pharma giant Pfizer (NYSE: PFE) is the second approved biosimilar to Amgen’s (Nasdaq: AMGN) Neupogen approved in the USA, and comes in the wake of FDA Commissioner Dr Scott Gottlieb’s efforts to speed biosimilars approvals.

The first was Novartis (NOVN: VX) generics subsidiary Sandoz’s Zarxio (filgrastim-sndz), which launched at a 15% discount to Neupogen in September 2015, after Amgen failed in its legal battle to prevent marketing of the copy version.