Federal Circuit: Biosimilar Marketing Notice Mandatory, Effective Post-Approval

A second Federal Circuit appeals panel has ruled that a biosimilar maker must give the reference product maker 180-day post-approval notice before launching its product, offering more legal clarity on the law's marketing notice provision as the Supreme Court considers whether to take up the issue. The U.S. Court of Appeals for the Federal Circuit handed down a ruling Tuesday (July 5) that would compel biosimilar-maker Apotex to provide reference product sponsor Amgen 180-day notice before launching its product, echoing...