Court ruling clears way for first U.S. biosimilar launch

The U.S. Court of Appeals for the Federal Circuit in Washington has ruled that Novartis AG’s Sandoz may begin selling the first copy of Amgen Inc.’s Neupogen as soon as Sept. 2.

The appeals court rejected arguments that Sandoz failed to follow regulatory rules when it applied to sell Zarxio, the first biosimilar approved in the United States.

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However, the launch of Zarxio could be delayed if Amgen either appeals the decision or is successful in a related patent case against Novartis. Neupogen is used to boost white blood cell counts to fight infections in cancer patients.

The appeal court ruled that federal law requires Sandoz to wait six months after FDA approval before marketing the drug.

"Sandoz, therefore, may not market Zarxio before 180 days from March 6, 2015, i.e., September 2, 2015," the appeals court ruling read.

The appeals panel sent the case back to district court in San Francisco to decide the issue of whether Zarxio infringes on Amgen’s patent for use of filgrastim, the active ingredient in Neupogen.

"We look forward to launching Zarxio on September 2 as the first U.S. biosimilar," Novartis spokesman Eric Althoff toldReuters.

Amgen has not announced its next step. It could ask an injunction to block sales of Zarxio until the patent issue is settled.