Amgen cannot stop
imminent sale of Neupogen copycat: appeals court
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[September 03, 2015] By
Andrew Chung
(Reuters) - A U.S. appeals court has
cleared the way for Novartis AG to launch the first biosimilar drug in
the United States as it declined on Wednesday to stop the sale of the
company's copycat version of Amgen Inc's blockbuster cancer drug
Neupogen.
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The U.S. Court of Appeals for the Federal Circuit in July said
Novartis could begin to market its biosimilar drug, to be sold under
the name Zarxio, after Sept. 2.
Amgen had sought an injunction while both companies ask the court to
clarify federal regulations on when close copies of biologic
medicines may be brought to market. The appeals court, based in
Washington, gave no reasons for rejecting Amgen's bid.
Novartis's generic drugs unit, Sandoz, has said in court papers that
it can begin to market Zarxio commercially on Thursday.
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Representatives from both companies could not immediately be reached
for comment.
Amgen sued Sandoz last October, alleging infringement of a patent on
Neupogen, its $1.2 billion-a-year medicine that boosts white blood
cell counts to fight infections in cancer patients.
While biosimilars aim to copy biologic products, which are made
inside living cells, they are not considered exact duplicates, such
as generic versions of more traditional pills.
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Insurers hope biosimilars will cost the public 40 percent to 50
percent less than the original brands.
Biosimilars, including a version of Neupogen, have been available in
Europe since 2006.
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