Drugmakers Ask Appeals Court to Review Ruling on Biosimilar Approval

Sandoz and Amgen are separately asking the full Federal Circuit Court of Appeals to review a July decision by a three-judge panel on the biosimilar approval pathway, saying the ruling is contrary to Congress’ intent in the Biologics Price Competition and Innovation Act.

Under last month’s ruling in Amgen Inc. et al. v. Sandoz Inc., the panel held that biosimilars makers must give 180 days’ notice before a product’s commercial launch, but that notice can’t be given ahead of FDA approval. The decision bars Sandoz from marketing its Neupogen (filgrastim) biosimilar Zarxio until Sept. 2.

In last week’s filing, Sandoz argues that the panel’s fragmented decision will delay patient access to all biosimilars for six months longer than Congress intended. The BPCIA notice provision calls for 180 days’ notice before an expected product launch and says nothing about the notice being after FDA approval, the drugmaker says. Doing so would be superfluous, since FDA approval is a public act, Sandoz adds.

The panel also held that manufacturers of the reference biological and the courts can’t compel a biosimilars applicant to comply with the BPCIA patent dispute resolution provisions, which require biosimilars makers to disclose relevant patent information in their abbreviated BLA to the brandmaker within 20 days of filing an application with the FDA.

Amgen argues that the majority of the panel erred on this matter, based on its interpretation that the word “shall” is not mandatory when read in the context of the entire BPCIA. The decision needs to be reconsidered, as it not only affects Zarxio, but other aBLAs pending before the FDA, Amgen says.

Sandoz initially gave Amgen notice of its intent to market its Neupogen biosimilar in July 2014, after submitting an aBLA for the chemotherapy treatment that May. The German drugmaker gave notice again when it received FDA approval on March 6 of this year, saying it could go to market at the latest on Sept. 2. — Jonathon Shacat