FDA Seeks To Accelerate Biosimilar Development By Easing Data Requirements

The U.S. Food and Drug Administration (FDA) significantly revised its approach to biosimilar drug development on October 29. Specifically, FDA issued a draft guidance recommending when comparative analytical assessments (CAA) may be used instead of comparative efficacy studies (CES) to demonstrate biosimilarity to a reference product in a Biologics License Application (BLA). The guidance reflects FDA's evolving perspective on using analytical technologies to reduce regulatory burdens and accelerate development timelines for biosimilar products licensed under Section 351(k) of the Public Health Service Act. Despite this data moderation, obstacles to biosimilar market access will remain, as discussed below in "Implications for Sponsors and Industry."