Novartis Closer to Selling Copy of Amgen's Neupogen

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 [e-mail]

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September 02, 2015 16:15 ET (20:15 GMT)

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