Appeals Court Halts Launch of Neupogen Biosimilar

A federal appeals court has granted a temporary injunction barring Sandoz from marketing its biosimilar of Amgen’s blockbuster chemotherapy drug Neupogen.

The injunction, handed down by the U.S. Court of Appeals for the Federal Circuit, marks the latest episode in the brandmaker’s efforts to block competition with Neupogen (filgrastim), following the FDA’s historic approval of Sandoz’ Zarxio (filgrastim-sndz) in March.

On March 19, a judge for the U.S. District Court for the Northern District of California 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 appealed, claiming the court erred because the patent-exchange and notice procedures of the law are phrased in mandatory language and described as being required.

Zarxio won FDA approval for all five Neupogen indications on March 6, the first under the 2010 biosimilars pathway.

A June 3 hearing date is set for the case, Amgen Inc. et al. v. Sandoz Inc.

Sandoz spokeswoman Liz Power says the firm expects the dispute to be resolved in its favor, allowing for Zarxio’s launch soon after. Amgen could not be reached for comment by press time.

Read the judge’s order at www.fdanews.com/05-07-15-amgenappeal.pdf. — John Bechtel