FDA Issues Guidance to Industry in Effort to Accelerate Development and Reduce Costs of Biosimilar Drugs

The U.S. Food and Drug Administration’s (FDA) new draft guidance may reduce the cost and time to market for some applicants with biosimilar Biologic License Applications (BLAs). This draft guidance pivots from requiring comparative efficacy studies (CES) to demonstrate interchangeability to reference products, but the FDA may still require some applicants to collect substantial amounts of data, including expensive clinical study data….
By: Stinson LLP