FDA said in briefing documents ahead of a July 13, 2016 meeting that Sandoz’s biosimilar GP2015 has “no clinically meaningful differences” with the US-licensed and EU-licensed versions of Enbrel ...

In the second straight resounding vote in favor of a biosimilar in as many days, Sandoz’s version of Amgen’s Enbrel earned unanimous support from an FDA panel Wednesday. With the 20-0 vote, Novartis’ ...

THOUSAND OAKS, Calif., and RADNOR, Penn., – New data from multiple studies evaluating the use of ENBREL® (etanercept), the only fully human TNF receptor, in patients with long-standing disease, as ...

FDA reviewers have found that Sandoz's GP2015, a biosimilar version of Amgen's Enbrel, is highly similar to the original product in terms of purity, safety, and potency. FDA said in briefing documents ...