Court Decision Could Allow Novartis To Sell Copy of Amgen's Neupogen -- Update
September 02 2015 - 4:22PM
Dow Jones News
By Peter Loftus
A federal appeals court in Washington denied Amgen Inc.'s
request for a temporary injunction to block Novartis AG from
selling a copycat version of the blockbuster drug Neupogen in the
U.S.
The decision by the U.S. Court of Appeals for the Federal
Circuit could clear the way for Novartis to begin selling Zarxio, a
knockoff version of Neupogen that was approved by the U.S. Food and
Drug Administration in March. The U.S. market accounted for more
than 70% of Amgen's $1.16 billion in global sales last year of
Neupogen, a drug prescribed to 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. But the product's
introduction has been held up by a legal dispute between Amgen and
Novartis.
The drug industry and its lawyers are 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.
A Novartis spokesman said the company welcomed Wednesday's
decision, but didn't provide plans for selling Zarxio. An Amgen
spokeswoman said the company will "compete effectively" but
declined to comment directly on the court decision.
The same appeals court issued a ruling in July that largely
sided with Novartis, but ordered an injunction on Zarxio's sale
until Wednesday. Amgen subsequently asked for a temporary
injunction that would bar the sale of Zarxio beyond Wednesday,
while Amgen pursues further legal options. The court denied Amgen's
request without explanation in an order issued Wednesday.
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 Amgen
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 Peter Loftus at peter.loftus@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
September 02, 2015 16:07 ET (20:07 GMT)
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