PRV Extension, Generic Labeling, Biosimilars Provisions In Year-End Bill

Congress’ year-end coronavirus relief and spending deal appears to include FDA-related provisions that would extend the agency’s rare disease priority review voucher program until 2024, allow biosimilars applicants to reference previously approved indications in their applications, give FDA authority to require that generic drug labels be updated, and clarify that orphan drugs and biologics must prove clinical superiority. The provisions are included in an unconfirmed text of the bill that was floating among lobbyists late Sunday evening (Dec. 20). The...