Novartis to Begin Selling Copy of Amgen's Neupogen in U.S.

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.

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September 03, 2015 03:45 ET (07:45 GMT)

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