New FDA Guidance on Approvals of Biosimilars

On Oct. 29, the Food and Drug Administration (FDA) issued new draft guidance aimed at streamlining how biosimilar and interchangeable biologics are approved. Instead of requiring extensive clinical trials, the agency is recommending a risk-based approach using advanced analytical testing and pharmacokinetic studies to support market entry of lower-cost alternatives.

With biologic drugs accounting for over half of overall U.S. drug spending, this guidance reflects a continued push to shorten drug development timelines, lower costs, enable increased competition, and expand patient access to affordable treatments.

Comments on the draft guidance are due within 60 days to the Federal Register.