Expedited Access to Biosimilars Act

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9661 Introduced in House (IH)]

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119th CONGRESS
  2d Session
                                H. R. 9661

   To amend the Public Health Service Act to codify that the default
expectation for licensure of biological products as biosimilar does not
  include clinical studies assessing pharmacodynamics or comparative
               clinical efficacy, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             July 14, 2026

 Mr. Langworthy (for himself and Ms. Schrier) introduced the following
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

   To amend the Public Health Service Act to codify that the default
expectation for licensure of biological products as biosimilar does not
  include clinical studies assessing pharmacodynamics or comparative
               clinical efficacy, 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 ``Expedited Access to Biosimilars
Act''.

SEC. 2. ASSESSMENT OF PHARMACODYNAMICS OR 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)--
                            (i) by striking ``item (aa) or (cc)'' and
                        inserting ``item (aa), (cc), or (dd)''; and
                            (ii) by striking ``and'' at the end; and
                    (B) by striking item (cc) and inserting the
                following:
                                            ``(cc) an assessment of
                                        pharmacokinetics and
                                        immunogenicity (which may rely
                                        on, or consist of, a clinical
                                        pharmacokinetics study or
                                        studies or a study or studies
                                        described in item (aa) or (dd),
                                        as appropriate); and
                                            ``(dd) subject to clause
                                        (iv), an additional clinical
                                        study or studies 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) Limitation on requiring additional
                        clinical study or studies.--The Secretary may
                        only require an additional clinical study or
                        studies described in clause (i)(I)(dd),
                        including a study or studies that include an
                        assessment of pharmacodynamics or efficacy, if
                        the Secretary determines that such study or
                        studies are necessary, in combination with the
                        other studies described in clause (i)(I), to
                        demonstrate biosimilarity and provides written
                        notice of such determination to the sponsor of
                        the proposed biosimilar biological product.
                        Such written notice shall be provided not later
                        than--
                                    ``(I) the date on which the
                                Secretary grants a request for a
                                biosimilar biological product
                                development meeting from such sponsor,
                                unless the Secretary describes in
                                writing why an assessment of the need
                                for such study or studies cannot be
                                made at that time; or
                                    ``(II) if no request for a
                                biosimilar biological product
                                development meeting is submitted or if
                                the Secretary was unable to make the
                                assessment under subclause (I), the
                                date that is 60 days after the date of
                                the submission of an application under
                                this subsection.''.
    (b) Repeal of Requirement Relating To Conduct of Reviews.--Section
351(k)(5) of the Public Health Service Act (42 U.S.C. 262(k)(5)) is
amended--
            (1) by striking subparagraph (B); and
            (2) by redesignating subparagraph (C) as subparagraph (B).
    (c) 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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