Federal Court Weighs Neupogen Biosimilar Appeal

June 10, 2015

A federal appeals court is considering whether to lift a temporary injunction that bars Sandoz from marketing its Zarxio-sndz biosimilar pending an outcome in patent infringement litigation involving reference product maker Amgen’s blockbuster chemotherapy drug Neupogen.

During a hearing last week, Sandoz urged a three-judge panel in the U.S. Court of Appeals for the Federal Circuit to lift the injunction immediately, saying it has fulfilled all legal requirements for marketing the biosimilar.

The court granted the injunction on May 5, following a denial by the U.S. District Court for the Northern District of California on March 19.

In the March ruling, U.S. District Judge Richard Seeborg also struck down Amgen’s bid to require Sandoz to again provide 180 days advance notice before Zarxio-sndz goes to market.

Sandoz gave Amgen the required notice when it applied for FDA approval last July, which means Zarxio-sndz should already be on the market, the generics maker told the three-judge panel. Sandoz also gave notice when it received FDA approval March 6, meaning it could go to market at the latest on Sept. 2, the company said.

Amgen countered that the law prohibits Sandoz from giving notice until after it obtains FDA approval.

Seeborg also ruled that the Biologics Price Competition and Innovation Act’s patent dispute resolution procedures are optional, meaning biosimilars may be approved and hit the market before they face a patent challenge.

Amgen’s appeal claims the court erred because the patent-exchange and notice procedures of the law are phrased in mandatory language and described as being required.

The appeals court did not indicate when it will issue a ruling in Amgen Inc. v. Sandoz Inc. — Jonathon Shacat