“Under [42 U.S.C.] ยง 262(l), an applicant that seeks FDA approval of a biosimilar must provide its application materials and manufacturing information to the manufacturer of the corresponding biologic within 20 days of the date the FDA notifies the applicant that it has accepted the application for review. The applicant then must give notice to the manufacturer at least 180 days before marketing the biosimilar commercially.”
1. “The first question presented by these cases is whether the requirement that an applicant provide its application and manufacturing information to the manufacturer of the biologic is enforceable by injunction.” 2. “The second question is whether the applicant must give notice to the manufacturer after, rather than before, obtaining a license from the FDA for its biosimilar.”
1. “We conclude that an injunction is not available under federal law, but we remand for the court below to decide whether an injunction is available under state law.” 2. “We conclude that an applicant may provide notice before obtaining a license.”
