# 2026-19166: FDA drafts plan for easier interchangeable biosimilar drugs 2026-19166, Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-09-18, effective Submit either electronic or written comments on this draft Strategy Document by November 17, 2026 to ensure that the Agency considers your comment on this draft Strategy Document before it begins work on the final version of the Strategy Document.; PRIA reads it as touching household money (as of 2026-09-25). - Canonical: https://policyrisk.com/federal-register/2026-19166 - As of: 2026-09-25 - Plain-text twin of the page above; the HTML and this file carry the same facts. ## Facts - Document number: 2026-19166 - Title: Biosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy Document - Type: Notice - Agencies: Health and Human Services Department; Food and Drug Administration - Citation: 91 FR 59140 - Published: 2026-09-18 - Effective: Submit either electronic or written comments on this draft Strategy Document by November 17, 2026 to ensure that the Agency considers your comment on this draft Strategy Document before it begins work on the final version of the Strategy Document. - Comments close: 2026-11-17 - Significant: no - Touches household money: yes - Regulation identifier numbers: none - Last updated: 2026-09-25 ## In one line FDA drafts plan for easier interchangeable biosimilar drugs ## Summary The FDA just shared a draft plan to help make interchangeable biosimilar drugs easier to develop and approve. This affects drug makers and patients who want more affordable medicine options. The FDA wants your feedback by November 17, 2026, before finalizing the plan, which supports innovation and smoother drug approvals through 2027. ## Abstract The Food and Drug Administration (FDA or Agency) is announcing the publication of a draft strategy document titled "BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document" (Strategy Document). This draft Strategy Document is intended to summarize the discussion that occurred at the FDA public workshop, "Advancing the Development of Interchangeable Products: Identifying Future Needs," held on September 19, 2025, and to describe FDA's future directions to support interchangeable biosimilar products. FDA is issuing this draft Strategy Document to fulfill a commitment FDA made in the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023 through 2027 (BsUFA III) to publish a post-workshop draft strategy document for public comment. ## Effects PRIA read - Draft Strategy to Support Biosimilars: benefit, low. The FDA published a draft Strategy Document that summarizes the September 19, 2025 public workshop and describes FDA's future directions to support development of interchangeable biosimilar products under the BsUFA III commitments for fiscal years 2023 through 2027. The Agency is accepting public c… - Education for Patients and Providers: benefit, low. FDA says it will provide educational resources for healthcare providers and patients about interchangeable biosimilar products to help build confidence in their safety and effectiveness. The draft Strategy Document summarizes this planned focus and is open for public comment through November 17, 20… - Focus on Science and Human Factors: benefit, low. The draft Strategy Document says FDA will continue to follow evolving science and address scientific topics such as analytical data considerations and user interface and human factors when supporting interchangeable biosimilar development. 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