NVS Novartis AG

By Neil MacLucas 

ZURICH-- Novartis AG said Thursday it would 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, Switzerland-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 drugs help to boost the white-blood-cell count in chemotherapy patients and others with compromised immune systems.

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.

Unlike generic drugs, which copy "classic" chemically-made drugs, biosimilars mimic biotechnology drugs made through more complex processes involving living cells. The results are a close, but not exact, copy.

The U.S. market accounted for more than 70% of Amgen's $1.16 billion in global sales of Neupogen last year.

Zarxio was the first biosimilar 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 Thousand Oaks, Calif.-based 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.

In Europe, which introduced its first biosimilar nearly a decade ago, these copycats have eroded sales of the original drug more gradually than "classic" generic drugs, which can cause sales of the original to plummet within months. Novartis launched biosimilar Neupogen under the name Zarzio in 2009, and it took four years to overtake sales of the original. There are now eight competing biosimilars for Neupogen in Europe, and together they account for nearly 80% of the market.

Denise Roland contributed to this article.

Write to Neil MacLucas at neil.maclucas@wsj.com

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(END) Dow Jones Newswires

September 03, 2015 05:09 ET (09:09 GMT)

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