Sandoz given backing from FDA advisory panel on Enbrel biosimilar

A US Food and Drug Administration advisory committee has unanimously recommended approval of a biosimilar version of the big-selling arthritis drug Enbrel (etanercept).

While the original drug is marketed by US biotech major Amgen (Nasdaq: AMGN), the GP2015 biosimilar version has been developed by Sandoz, the generics and biosimilars division of Swiss pharma giant Novartis (NOVN: VX).

All 20 members of the FDA’s Arthritis Advisory Committee backed approval of GP2015, having received robust evidence from Sandoz to show its similarity to the reference product.