[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1414 Introduced in Senate (IS)]

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119th CONGRESS
  1st Session
                                S. 1414

To amend the Public Health Service Act to provide that clinical studies 
 required for licensure of biological products as biosimilar shall not 
       be required to include the assessment of immunogenicity, 
          pharmacodynamics, or comparative clinical efficacy.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 10, 2025

   Mr. Paul introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act to provide that clinical studies 
 required for licensure of biological products as biosimilar shall not 
       be required to include the assessment of immunogenicity, 
          pharmacodynamics, or comparative clinical efficacy.

    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 ``Expedited Access to Biosimilars 
Act''.

SEC. 2. ASSESSMENT OF IMMUNOGENICITY, PHARMACODYNAMICS, OR COMPARATIVE 
              CLINICAL EFFICACY IN CLINICAL STUDIES REQUIRED FOR 
              LICENSURE OF BIOLOGICAL PRODUCTS AS BIOSIMILAR.

    (a) In General.--Section 351(k)(2)(A) of the Public Health Service 
Act (42 U.S.C. 262(k)(2)(A)) is amended--
            (1) in clause (i)(I)--
                    (A) in item (bb), by striking ``and'' at the end; 
                and
                    (B) by striking item (cc) and inserting the 
                following
                                            ``(cc) a clinical study or 
                                        studies assessing 
                                        pharmacokinetics that are 
                                        sufficient to demonstrate 
                                        safety, purity, and potency; 
                                        and
                                            ``(dd) subject to clause 
                                        (iv), a clinical study or 
                                        studies that are sufficient to 
                                        demonstrate safety, purity, and 
                                        potency in 1 or more 
                                        appropriate conditions of use 
                                        for which the reference product 
                                        is licensed and intended to be 
                                        used and for which licensure is 
                                        sought for the biological 
                                        product;''; and
            (2) by adding at the end the following:
                            ``(iv) Clinical studies.--
                                    ``(I) In general.--Subject to 
                                subclause (II), the Secretary may 
                                determine, in the Secretary's 
                                discretion, that a clinical study 
                                required under clause (i)(I)(dd) shall 
                                include the assessment of 
                                immunogenicity, pharmacodynamics, or 
                                comparative clinical efficacy.
                                    ``(II) Requirement.--The Secretary 
                                may only require the assessment of 
                                immunogenicity, pharmacodynamics, or 
                                comparative clinical efficacy pursuant 
                                to a determination under subclause (I) 
                                if the Secretary provides to the 
                                applicant notice of the requirement, 
                                including a written justification of 
                                the basis for such determination, not 
                                later than the earliest date on which 
                                the applicant may file the application 
                                under this subsection.''.
    (b) Applicability.--The amendments made by subsection (a) shall 
apply with respect to an application submitted under section 351(k) of 
the Public Health Service Act (42 U.S.C. 262(k)) on or after the date 
of enactment of this Act.
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