(Reuters) - A U.S. appeals court has blocked the sale of Novartis AG’s recently approved “biosimilar” form of Neupogen, the blockbuster Amgen Inc drug used to prevent infections in cancer patients.
A lower court judge rejected Amgen’s request for an injunction. The U.S. Court of Appeals for the Federal Circuit ruled on Tuesday, however, that the injunction could take effect while Amgen’s appeal is pending. Oral arguments on the appeal have been set for June 3.
In a statement, Amgen said it is pleased with the ruling. Novartis said it looks forward to a “prompt resolution” of the appeal so it can launch its drug “in the near future.”
The Novartis 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.
Because biosimilars are made in living cells, they are not considered exact duplicates of original brands. Insurers are hoping biosimilars will be sold for discounts of 40 percent to 50 percent from the cost of original brands in the United States. 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 approved Zarxio in March for the same five conditions for which Neupogen is used among cancer patients undergoing various treatments.
Reporting by Dan Levine; Editing by Grant McCool and Andre Grenon