US Federal Circuit rules 180-day notice on biosimilars is mandatory

The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration review.

This report was posted by Zachary Brennan on the US Regulatory Affairs Professionals Society ‘Focus’ website.

The ruling has major implications for when biosimilars can be launched and it follows the US Supreme Court’s request in late June that the Solicitor General provide more information on whether the highest court in the USA should review the terms of this so-called “patent dance,” the rules of which govern how biosimilar and reference product manufacturers must work out their patent issues as established by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).