Expedited Access to Biosimilars Act

[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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