Federal Circuit: FDA Approval Required Before Biosimilar Applicant Provides 180-Day Notice
Biosimilars makers must have FDA approval of their product before giving the reference product manufacturer 180-day notice of first commercial marketing, the Federal Circuit Court of Appeals ruled last week — in a decision that bars Sandoz from marketing its Neupogen biosimilar until Sept. 2.
The court also concluded that the Biologics Price Competition and Innovation Act’s patent dispute resolution provisions — which require biosimilars makers to disclose the information in their aBLA within 20 days of filing an application with the FDA — are optional because the law also recognizes that some applicants will choose not to comply. In that case, the court notes, the brandmaker has the clear remedy of suing the biosimilars company for patent infringement.
“Because Sandoz took a path expressly contemplated by the BPCIA, it did not violate the BPCIA by not disclosing its aBLA and the manufacturing information by the deadline,” the Federal Circuit writes. Amgen eventually obtained the aBLA through discovery in the lawsuit.
Sandoz initially gave Amgen notice of its intent to market its Neupogen (filgrastim) biosimilar Zarxio 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.
But the court disagreed, saying the earliest Sandoz can launch Zarxio (filgrastim-sndz) is Sept. 2, 180 days from March 6.
The decision in Amgen Inc. et al. v. Sandoz Inc. partially overturns a ruling in the U.S. District Court for the Northern District of California that had struck down Amgen’s bid to require Sandoz to provide the 180 days notice only after Zarxio had been approved.
Kurt Karst, an attorney with Hyman Phelps & McNamara says the Federal Circuit’s interpretation of the disclosure requirement will be used primarily by biosimilar applicants of older biological products, where there isn’t robust patent coverage, as opposed to new products, where the biosimilars maker and brandmaker would want to trim down and agree on a list of patents to be litigated.
Amgen declined to comment on a possible appeal. Sandoz could not be reached for comment by press time. — Jonathon Shacat