FDA Approves Novartis's Biosimilar to Amgen's Enbrel
August 30 2016 - 6:31PM
Dow Jones News
By Maria Armental
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 maria.armental@wsj.com
(END) Dow Jones Newswires
August 30, 2016 18:16 ET (22:16 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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