FDA Approves Novartis's Biosimilar to Amgen's Enbrel

Novartis AG's lower-priced replica of Amgen's rheumatoid arthritis and psoriasis drug Enbrel has been approved in the U.S. to treat multiple inflammatory diseases, the company said Tuesday.

The so-called biosimilar to etanercept will be sold under the name Erelzi. It is the third biosimilar approved in the U.S.

Novartis's Zarxio, rival to Amgen's Neupogen, was the first such drug approved in the U.S.

"The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases," Dr. Janet Woodcock, director of the Food and Drug Administration's Center for Drug Evaluation and Research, said in a news release.

Erelzi, which is also being reviewed by European health regulators, is administered by injection. The most serious side effects include possibly fatal infections, such as tuberculosis, and cases of unusual cancers that were reported in children and teenage patients, the company said.

Enbrel—which Amgen sells in the U.S. and Canada, and Pfizer sells elsewhere—competes with AbbVie Inc.'s top-selling drug Humira. Last year, the drug accounted for about $5.36 billion, or one-quarter, of Amgen's total product sales. Amgen is trying to develop a biosimilar to Humira.

Write to Maria Armental at [e-mail]

(END) Dow Jones Newswires

August 30, 2016 18:35 ET (22:35 GMT)

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