Court Decision Could Allow Novartis To Sell Copy of Amgen's Neupogen

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 new, 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.

Write to Peter Loftus at [e-mail]

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(END) Dow Jones Newswires

September 02, 2015 16:01 ET (20:01 GMT)

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