Biosimilars and federal preemption in the USA

Abstract

Summary This article reports on the recent decision by the Court of Appeals for the Federal Circuit (“Federal Circuit”) in Amgen v. Sandoz on remand from the U.S. Supreme Court. The Supreme Court held that a biosimilar applicant cannot be compelled under federal law to provide a copy of its abbreviated biologics license application (“aBLA”) and manufacturing information to the reference product sponsor (“RPS”) as required by the Biologics Price Competition and Innovation Act (“BPCIA”). The Supreme Court remanded the case to the Federal Circuit to determine whether there was any remedy under California state law available to Amgen, and if so, whether such remedy is preempted by the BPCIA. The Federal Circuit held that the BPCIA preempts state law remedies for a biosimilar applicant’s failure to comply with the BPCIA. This article also briefly discusses three other recent cases involving situations where the biosimilar applicant initiates the BPCIA information exchange process but provides only partial or no manufacturing information to the RPS or fails to complete the process by opting out at some later stage of the process.