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www.fdanews.com/articles/173494-sandoz-wins-fda-acceptance-for-biosimilar-enbrel

Sandoz Wins FDA Acceptance for Biosimilar Enbrel

October 8, 2015

Sandoz says the FDA has accepted its second biosimilar application, this one for a copy of Amgen’s autoimmune disease drug Enbrel, whose global sales of nearly $9 billion made it the world’s fifth-biggest selling medicine in 2014.

Enbrel (etanercept) is a TNF-alpha inhibitor intended to treat autoimmune diseases, including rheumatoid arthritis and psoriasis.

Sandoz’s submission is based on two pivotal clinical studies showing the proposed biosimilar is essentially its reference product, the drugmaker said.

Last month, Sandoz launched the first biosimilar in the U.S., Zarxio (filgrastim-sndz), which references Amgen’s chemotherapy drug Neupogen (filgrastim). Sandoz immediately priced the biosimilar 15 percent cheaper than the brandname product.

Merck and Samsung Bioepis won approval for a biosimilar to etanercept in South Korea last month, and a copy is on the way in Europe where Samsung is working with Biogen. The Merck/Samsung collaboration performed well in clinical trials earlier this year. — Kellen Owings