U.S. Supreme Court Allows Early Notice for Biosimilars under BPCIA

Yesterday, in Sandoz v. Amgen, the U.S. Supreme Court held that under the Biologics Price Competition and Innovation Act: (1) a biosimilar applicant cannot be compelled by federal injunction to provide its application and manufacturing information to the brand-name manufacturer, although the Federal Circuit is to decide on remand whether an injunction under state law is available; and (2) a biosimilar applicant need not wait until it has received FDA approval for its biosimilar to provide a 180 day notice of commercial marketing.