Nothing to See Here: FDA Issues Interchangeable Biosimilars Strategy Document

One year after hosting a public workshop (“Advancing the Development of Interchangeable Products: Identifying Future Needs”), and as part of its BSUFA III commitments, FDA, on September 18, 2026, published for comment a strategy document entitled “BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document” (Strategy Document).

The Strategy Document summarizes the public workshop discussion and describes FDA’s future directions to support interchangeable biosimilar products while identifying future goals and priorities for the FDA’s biosimilar programs.  It further outlines the “significant obstacles” that manufacturers and stakeholders have faced in interchangeable data development, market access, and substitution.  It details the confusion among stakeholders, as well as hurdles in communication between FDA and such stakeholders, which ultimately led to a call for more comprehensive and practical guidance addressing specific development scenarios.   Additionally, workshop participants identified device-related human factors as a significant hurdle, including evaluation requirements such as Use-Related Risk Analysis and side-by-side comparison of physical characteristics, tasks, and labeling.  Specifically, industry asked for clarity on comparative analysis expectations, delivery device considerations, and other product-specific development scenarios.

The most significant takeaway from the Strategy Document is its articulation of an evolving scientific approach to what evidence is needed to demonstrate interchangeability.  But this presents little that’s new, as FDA has been slowly implementing these types of changes for a while now.   Nevertheless, it is both a regulatory milestone—a required BsUFA III deliverable—and it is a strategic signal of where the FDA intends to take interchangeable biosimilar policy—toward science-led, analytically grounded, and less burdensome development pathways that aim to expand patient access.

Comments on the Strategy Document are due November 17, 2026.

On top of the Strategy Document, FDA announced a BSUFA IV meeting being held on October 26, 2026 to discuss proposed recommendations and provide stakeholders an opportunity to share input on the recommendations.  The proposed BSUFA IV Commitment Letter is available here.