High Court to Review Whether 180-Day Notification Is Required for Biosimilar Launch

The Supreme Court has agreed to hear a case centered on whether a 180-day notification is mandatory or optional — when the appropriate disclosures are made — before a biosimilar launch.

The high court’s decision would have far-reaching consequences — beyond Sandoz’s appeal to review the lawsuit against Amgen — setting a precedent on how the information exchange processes under the Biologics Price Competition and Innovation Act should be interpreted and when biosimilars should be allowed to reach the market. The court decided to hear the case following the acting solicitor general’s urging.

Last February, Sandoz appealed to the Supreme Court after the U.S. Court of Appeals for the Federal Circuit concluded that the 180-day notification is required, unless a biosimilar producer discloses their intent to launch the product and resolves patent disputes ahead of the approval.