FDA Approves Amgen's Biosimilar Version of Humira
September 23 2016 - 6:56PM
Dow Jones News
By Ezequiel Minaya
U.S. regulators approved Amgen Inc.'s copy of the AbbVie Inc.'s
anti-inflammatory treatment, Humira, which was the second-biggest
selling drug in 2015.
Amgen's drug, known as Amjevita, is only the fourth so-called
biosimilar -- which are copies of complex biotech medicines --
approved by the U.S. Food and Drug Administration. Biosimilars were
authorized as part of the federal health-care overhaul to reduce
spending on such biotech drugs, much like generics have cut the
costs of pills.
Amgen shares added a dime to $174.90 in after-hours trading,
while AbbVie added 2 cents to $65.
Last month, AbbVie filed a patent-infringement lawsuit against
Amgen, seeking to block sales of the biosimilar. The lawsuit
alleged that Amgen violated AbbVie's patents, and the suit asked
the court to keep the copy off the market if it gains FDA
approval.
Calls Friday to Amgen and AbbVie were unsuccessful.
Humira, which has a list price of $53,260 a year, had $8.4
billion in sales last year and accounts for about 60% of AbbVie's
revenue.
In a prepared statement, the FDA said Amgen's Amjevita proved to
be a biosimilar of Humira based on clinical safety and
effectiveness data, among other metrics.
Biosimilars, long available in other markets, were first
approved in the U.S. in March 2015. It remains unclear if the new
biosimilars are generating the degree of cost savings that some
expected.
"The biosimilar pathway is still a new frontier and one that we
expect will enhance access to treatment for patients with serious
medical conditions," said Janet Woodcock, director of the FDA's
Center for Drug Evaluation and Research, on Friday.
Write to Ezequiel Minaya at ezequiel.minaya@wsj.com
(END) Dow Jones Newswires
September 23, 2016 18:41 ET (22:41 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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