Biosimilar Inspection Modernization Act of 2025

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [S. 3510 Introduced in Senate (IS)] <DOC> 119th CONGRESS 1st Session S. 3510 To improve the inspections of drug establishments engaged in the manufacture, preparation, propagation, or processing of biosimilar biological products conducted by the Food and Drug Administration, and for other purposes. _______________________________________________________________________ IN THE SENATE OF THE UNITED STATES December 16, 2025 Mr. Budd (for himself and Ms. Hassan) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions _______________________________________________________________________ A BILL To improve the inspections of drug establishments engaged in the manufacture, preparation, propagation, or processing of biosimilar biological products conducted by the Food and Drug Administration, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Biosimilar Inspection Modernization Act of 2025''. SEC. 2. DEFINITIONS. In this Act-- (1) the term ``biosimilar biological product'' means a biological product licensed under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)); (2) the term ``biosimilar biological product establishment'' means an establishment engaged in the manufacture, preparation, propagation, or processing of a biosimilar biological 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) the term ``Secretary'' means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs. SEC. 3. PUBLIC MEETING AND REPORT ON MUTUAL RECOGNITION AGREEMENTS. (a) Public Meeting.--Not later than 180 days after the date of enactment of this Act, the Secretary s