FDA approves Sandoz's Enbrel biosimilar

The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) said FDA approved a BLA for Erelzi etanercept-szzs ( GP2015), a biosimilar of Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN). Erelzi is approved in all indications included on Enbrel's label. Novartis spokesperson Eric Althoff said "it is too early to speculate" about launch timing or a price for the biosimilar.

In February, Amgen filed suit against Sandoz, claiming the biosimilar infringes on five Enbrel patents. According to lawsuit-related documents filed this month, both parties have agreed to a preliminary injunction barring Sandoz from selling Erelzi and a trial has been scheduled for April 17, 2018 (see BioCentury Extra, Feb. 29). ...