US Supreme Court Permits Earlier Biosimilar Launches; Penalty For Declining Patent Dance Uncertain

The US Supreme Court handed biosimilar sponsors a victory in ruling that they do not have to wait until FDA approval to provide 180-day notice of intent to market their products. But it remains to be seen if they could face an injunction under state law for not providing their application and manufacturing process information to innovator companies.

But the court's unanimous June 12 opinion in Sandoz Inc. v. Amgen Inc. gives industry only partial clarity on the implementation of the Biologics Price Competition and Innovation Act (BPCIA)