U.S. judge rejects Amgen bid to block 'biosimilar' Neupogen

[March 20, 2015]  By Ransdell Pierson

NEW YORK (Reuters) - A U.S. judge on Thursday denied Amgen Inc's bid to block the sale of Novartis AG's recently approved "biosimilar" form of Neupogen, Amgen's blockbuster drug used to prevent infections in cancer patients.

The drug, Zarxio, contains the same active ingredient as Amgen's $1.2 billion-a-year Neupogen, and once launched, would become the first biosimilar in the United States.

Kristen Davis, a spokeswoman for Amgen, said in an emailed statement that the company plans to appeal the decision by U.S. District Judge Richard Seeborg of San Francisco federal court.

The judge denied Amgen's request for a preliminary injunction to prevent Novartis' Sandoz unit from launching its copycat drug. Swiss drugmaker Novartis previously agreed to delay its U.S. launch until the court's decision on the preliminary injunction, or until April 10, whichever came first.
 

It was not immediately clear how long Amgen's appeal would take, or whether Novartis might launch its biosimilar before an appeals court decision is rendered. If Novartis were to initiate such an "at-risk" launch, it might later have to pay costly damages in the event that Amgen's patent is declared valid and enforceable by the appeals court.

"Given the importance of this case for future biosimilars, we agreed with Amgen before this hearing to jointly request expedited review of any appeal to the Federal Circuit," Novartis said in an emailed statement on Thursday.

Because biosimilars are made in living cells, they are not considered exact duplicates of original brands. Insurers are hoping that biosimilars will be sold for discounts of 40 to 50 percent from the cost of original brands in the United States, but Novartis has not yet disclosed the intended U.S. price for Zarxio. Biosimilars have been on the market since 2006 in Europe.

The U.S. Food and Drug Administration in March approved Zarxio for the same five conditions for which Neupogen is used - among cancer patients undergoing various treatments.

(Additional reporting by Dan Levine in San Francisco; Editing by Grant McCool)

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