US FDA accepts Sandoz' biosimilar application for Amgen's Enbrel

The US Food and Drug Administration has accepted the regulatory application by Swiss drug major Novartis’ (NOVN: VX) generics unit Sandoz, for a biosimilar version of Amgen's (Nasdaq: AMGN) Enbrel (etanercept).

Biosimilars are a copy of approved biological products. They are touted to have highly similar properties to regulatory approved biologics. However, since they are not exact imitations, the manufacturers are required to prove via clinical trials that the product has intended impact.

Mark McCamish, head of global biopharmaceutical and oncology injectables development at Sandoz, said: "We believe we are the first company to receive FDA file acceptance of a biosimilar version of etanercept. Anti-TNFs will continue to play a leading role in immunology treatment and the acceptance of our regulatory submission by the FDA today is a significant step towards increasing patient access to these life-changing medicines."