Federal Circuit Holds That Amendments to Biosimilar’s BLA Do Not Trigger Anew BPCIA’s Notice of Commercial Marketing Provision
Under Section 262(l)(8)(A) of the BPCIA, a biosimilar maker must provide notice to the reference product sponsor 180 days before the date of first commercial marketing of the biosimilar. While the Supreme Court has held that such notice can be provided at any time, including before a biosimilar maker’s abbreviated biologics license application (aBLA) has been approved, the statute makes clear that a biosimilar cannot be launched without a notice of commercial marketing. In Genentech, Inc. v. Immunex Rhode Island Corp., No. 2019-2155 (Fed. Cir. July 6, 2020), the Federal Circuit held that supplements to a biosimilar’s aBLA do not trigger a new Section 262(l)(8)(A) requirement.