The Biologics Price Competition and Innovation Act of 2010 (BPCIA) created FDA’s biosimilar approval pathway. The first biosimilar was approved in 2015. As of January 2022, there are more than 30 FDA-approved biosimilars with dozens more in the queue. The Biosimilar User Fee Act (BsUFA) is a law authorizing FDA to assess and collect fees from drug manufacturers that submit BLAs for FDA’s review and approval. BsUFA was originally enacted in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA) for a period of five years. Each subsequent reauthorization requires industry and FDA to negotiate commitments to enhance and improve the review process to facilitate timely access to biosimilar medicines. FDA assesses and collects user fees to ensure the Agency has the necessary resources to fulfill the agreed upon commitments. BsUFA III will constitute the second reauthorization of this Act.
To learn more, download the fact sheet.