S. 3510 — Biosimilar Inspection Modernization Act of 2025

This section defines, for purposes of the Act, (1) "biosimilar biological product" as a biological product licensed under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)); (2) "biosimilar biological product establishment" as an establishment engaged in the manufacture, preparation, propagation, or processing of such a product and registered under subsection (b)(1), (c)(1), or (i) of section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360); and (3) "Secretary" as the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs.

This section directs the Secretary of Health and Human Services, not later than 180 days after enactment, to conduct a public meeting on the use of mutual recognition agreements (i.e., arrangements with foreign regulators to recognize each other's facility inspections) for FDA inspections under section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) of biosimilar biological product establishments (i.e., facilities producing lower-cost versions of FDA-approved biologic drugs). Not later than 180 days after that meeting, the Secretary must submit to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce, and publicly release, a report with recommendations on such use (including potential expansion beyond compliance inspections to remote assessments, trusted foreign partner inspections, and virtual expert interactions).

This section directs the Secretary of Health and Human Services to update Food and Drug Administration (FDA) inspection processes and tools to implement a risk-based approach for establishments manufacturing, preparing, propagating, or processing biosimilar biological products (i.e., biological products approved as highly similar to an FDA-licensed reference product under the Public Health Service Act). Specifically, the updates must enable FDA (1) to increase use of remote regulatory assessments under section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), consistent with FDA guidance titled “Conducting Remote Regulatory Assessments—Questions and Answers” (June 24, 2025, or successor); and (2) to maximize alternative tools from that guidance to improve inspection efficiency.

This section directs the Secretary of Health and Human Services, not later than one year after the date of enactment, to develop and publish a strategic plan on ways the Food and Drug Administration (FDA) will address challenges in inspecting domestic biosimilar biological product establishments (i.e., facilities producing products approved under the abbreviated biosimilar licensure pathway in section 351(k) of the Public Health Service Act, 42 U.S.C. 262(k)). The plan must cover (1) recruiting and retaining inspection staff, (2) challenges specific to inspecting such establishments, (3) improving internal FDA communications among personnel involved in such inspections, and (4) expanding external communications with 351(k) application sponsors, including on potential inspection requirements and resolving inspection questions earlier in the review process.