Biosimilar Inspection Modernization Act of 2025

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3510 Introduced in Senate (IS)]

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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 shall conduct a public meeting on 
the use of mutual recognition agreements for purposes of carrying out 
inspections under section 704 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 374) of establishments engaged in the manufacture, 
preparation, propagation, or processing of a biosimilar biological 
product, including a discussion of--
            (1) how mutual recognition agreements are utilized with 
        respect to the inspection of biosimilar biological product 
        establishments, and areas for improvements in such inspections 
        conducted pursuant to such agreements; and
            (2) areas in which use of mutual recognition agreements 
        could be expanded to apply beyond compliance inspections under 
        section 704 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 374), including for use in conjunction with remote 
        regulatory assessments, inspections conducted by trusted 
        foreign partners identified by the Food and Drug 
        Administration, and virtual interactions with subject matter 
        experts.
    (b) Report.--Not later than 180 days after the public meeting under 
subsection (a) is conducted, the Secretary shall issue to the Committee 
on Health, Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of Representatives, and 
make publicly available, a report that includes recommendations on the 
use of mutual recognition agreements for purposes of conducting 
inspections of biosimilar biological product establishments.

SEC. 4. ENSURING FLEXIBILITY IN INSPECTION TOOLS.

    The Secretary shall update inspection processes and existing tools 
to advance a risk-based approach to evaluate, including conducting 
inspections, of establishments engaged in the manufacture, preparation, 
propagation, or processing of biosimilar biological products to enable 
the Food and Drug Administration to--
            (1) increase utilization of remote regulatory assessments 
        under section 704 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 374), in accordance with the guidance issued by the 
        Food and Drug Administration, titled ``Conducting Remote 
        Regulatory Assessments--Questions and Answers'' (June 24, 2025) 
        (or any successor guidance); and
            (2) maximize the use of alternative tools set forth in the 
        guidance described in paragraph (1) to improve inspection 
        efficiency.

SEC. 5. FDA STRATEGIC PLAN ON DOMESTIC INSPECTION IMPROVEMENTS FOR 
              BIOSIMILAR BIOLOGICAL FACILITIES.

    Not later than 1 year after the date of enactment of this Act, the 
Secretary shall develop and publish a strategic plan on ways the Food 
and Drug Administration will address challenges with respect to the 
inspection of domestic biosimilar biological product establishments, 
including regarding--
            (1) recruiting and retaining inspections staff;
            (2) challenges specific to inspecting domestic biosimilar 
        biological product establishments;
            (3) improving internal communication among all Food and 
        Drug Administration personnel involved in inspections of 
        biosimilar biological product establishments; and
            (4) expanding opportunities for external communications 
        with sponsors of applications under section 351(k) of the 
        Public Health Service Act (42 U.S.C. 262(k)), including 
        informing such sponsors about potential inspection requirements 
        and resolving outstanding inspection related questions earlier 
        in the review process.
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