SCOTUS: 180-Day Biosimilar Exclusivity Does Not Have to Wait for FDA Approval

Biosimilars manufacturers may start the clock on 180-day countdowns to marketing at any time, without waiting first for FDA approval, the U.S. Supreme Court ruled in a decision that reshapes the patent dance between biosimilar applicants and reference holders, and could affect the course of billions of dollars in the industry.

Sandoz — which developed the first U.S.-approved biosimilar, Zarxio (filgrastim-sndz), based on Amgen’s Neupogen — argued that those 180 days can begin any time and that waiting for FDA approval was not required. In addition, Sandoz did not provide Amgen with a copy of its biosimilar application, another early step required in the process.

The court also agreed with a lower Federal Circuit decision on disclosure of abbreviated BLAs, which had favored Sandoz’s decision to not provide Amgen its application. The refusal does not serve as grounds for infringement and remediation alone, though submitting a product application to the FDA can, the Supreme Court said, adding that those federal disclosure requirements are not enforceable by injunction, although injunctions may work under individual state laws.