Biosimilar Applicants Cannot Avoid 180-Day Notice Requirement
Companies currently holding the exclusive rights to biologics should be celebrating the Federal Circuit’s decision released earlier this week. In Amgen v. Apotex, the Court held that all biosimilar applicants must provide a 180-day notice to owners of the NDA for the referenced biologic before engaging in commercial marketing of their biosimilars. Amgen Inc. v.…