Novartis to Begin Selling Copy of Amgen's Neupogen in U.S.
September 03 2015 - 04:00AM
Dow Jones News
ZURICH—Novartis AG said Thursday it will begin selling the first
biosimilar drug in the U.S. after an appeals court denied Amgen
Inc.'s request to block the Swiss drug maker's sale of its copycat
version of blockbuster remedy Neupogen.
Basel-based Novartis's move followed the decision Wednesday by
the U.S. Court of Appeals for the Federal Circuit that cleared the
way for the firm's Sandoz unit to start selling Zarxio, a knockoff
version of Neupogen that was approved by the U.S. Food and Drug
Administration in March.
The drug industry and its lawyers have been closely watching the
Neupogen biosimilar case because the outcome could shape the path
to market for a coming wave of biosimilar drugs that are expected
to cost less than the original brands.
The U.S. market accounted for more than 70% of Amgen's $1.16
billion in global sales of Neupogen last year, a drug for treating
chemotherapy patients.
Zarxio was the first biosimilar—a copy of a biotechnology
drug—approved by the FDA under abbreviated criteria enabled by a
provision of the 2010 Affordable Care Act. However the product's
introduction has been delayed by a legal dispute between Amgen and
Novartis.
Novartis hasn't announced a price for Zarxio. In Europe, where
biosimilars have been available for several years, they typically
cost 15% to 30% less than the original brands.
The dispute began when Amgen filed a lawsuit in federal court in
San Francisco last year, accusing Novartis of failing to disclose
certain information about its copycat product to Amgen, which the
U.S. firm said was required under the new criteria for FDA approval
of biosimilars. Amgen also alleged Zarxio would infringe upon a
patent for Neupogen. Novartis denies the allegations.
Write to Neil MacLucas at neil.maclucas@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
September 03, 2015 03:45 ET (07:45 GMT)
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