Biosimilar Tentative Approvals Could Flow From US Supreme Court Case

The US Supreme Court’s forthcoming decision in a dispute over the Biologics Price Competition and Innovation Act’s (BPCIA) “patent dance” could lead to a new regulatory framework for biosimilar tentative approvals and new thinking by biosimilar sponsors on when to provide 180-day notice of commercial launch, one attorney predicts.

Speaking at the Food and Drug Law Institute’s recent annual meeting, Chad Landmon, a partner at Axinn, Veltrop and Harkrider, suggested there could be pressure on FDA to start granting...