Federal Register #FDA-2025-N-2787

FDA Draft Strategy on Interchangeable Biosimilar Product Development

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has released a draft strategy document focused on future needs for developing interchangeable biosimilar products. - Government Buyer: - Food and Drug Administration (FDA) - Department of Health and Human Services - Purpose: - Publication of the "BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document" - Summarizes outcomes from an FDA public workshop - Outlines future directions for supporting interchangeable biosimilar product development - Public Engagement: - Invites public comment to inform the final strategy - Procurement Details: - No products or services are being requested - No OEMs, vendors, part numbers, or quantities mentioned - Notable Requirements: - Informational notice only; no procurement or award involved

Description

The Food and Drug Administration (FDA) announces the availability of a draft strategy document titled "BsUFA III Future Needs in the Development of Interchangeable Products Post-Workshop Strategy Document." This document summarizes discussions from the FDA public workshop held on September 19, 2025, and outlines FDA's future directions to support interchangeable biosimilar products. The draft strategy document is published to fulfill a commitment made in the BsUFA reauthorization letter for fiscal years 2023-2027 and invites public comment. Comments are due by November 17, 2026.

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