Novartis wins US OK for biosimilar version of Amgen's Enbrel

August 30, 2016 by The Associated Press

U.S. regulators have approved the first near-copy of Enbrel, drugmaker Amgen's pricey biologic medicine for treating rheumatoid arthritis and other immune system disorders.

The follow-up version of Enbrel, dubbed Erelzi, was developed by Swiss drug giant Novartis, which would not disclose the planned list price for Erelzi.

Novartis also couldn't say when the new medicine will be launched by its Sandoz unit, which makes and "biosimilars"—nearly identical versions of produced in living cells.

Erelzi is the third biosimilar drug approved by the Food and Drug Administration. It's also the second approved biosimilar developed by Novartis, and the second that will compete with an Amgen drug.

Enbrel was first approved in 1998. It can cost about $4,000 per month without insurance.

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