Biosimilar Red Tape Elimination Act

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1954 Introduced in Senate (IS)]

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119th CONGRESS
  1st Session
                                S. 1954

       To improve the requirements for making a determination of
 interchangeability of a biological product and its reference product.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                              June 4, 2025

 Mr. Lee (for himself, Mr. Lujan, Mr. Paul, 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 requirements for making a determination of
 interchangeability of a biological product and its reference product.

    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 Red Tape Elimination
Act''.

SEC. 2. BIOSIMILAR BIOLOGICAL PRODUCTS.

    (a) In General.--Section 351(k) of the Public Health Service Act
(42 U.S.C. 262(k)) is amended--
            (1) in the subsection heading, by striking ``or
        Interchangeable'';
            (2) in paragraph (2)--
                    (A) by striking subparagraph (B);
                    (B) by redesignating clauses (ii) and (iii) of
                subparagraph (A) as subparagraphs (B) and (C),
                respectively, and adjusting the margins accordingly;
                    (C) in subparagraph (A)--
                            (i) in clause (i), by redesignating
                        subclauses (I) through (V) as clauses (i)
                        through (v), respectively, and adjusting the
                        margins accordingly;
                            (ii) in clause (i), as so redesignated by
                        clause (i) of this subparagraph, by
                        redesignating items (aa) through (cc) as
                        subclauses (I) through (III), respectively, and
                        adjusting the margins accordingly; and
                            (iii) by striking ``(a) in general'' and
                        all that follows through ``An application
                        submitted under this subsection shall include
                        information'' and inserting the following:
                    ``(A) In general.--An application submitted under
                this subsection shall include information'';
                    (D) in subparagraph (B), as so redesignated by
                subparagraph (B) of this paragraph, by striking
                ``clause (i)(I)'' and inserting ``subparagraph
                (A)(i)''; and
                    (E) in subparagraph (C), as so redesignated by
                subparagraph (B) of this paragraph, by redesignating
                subclauses (I) through (III) as clauses (i) through
                (iii), respectively, and by adjusting the margins
                accordingly;
            (3) by amending subparagraph (A) of paragraph (3) to read
        as follows:
                    ``(A) the Secretary determines that the information
                submitted in the application (or the supplement) is
                sufficient to show that the biological product is
                biosimilar to the reference product; and'';
            (4) by amending paragraph (4) to read as follows:
            ``(4) Interchangeability.--
                    ``(A) In general.--A biological product licensed
                under this subsection shall be deemed to be
                interchangeable with the reference product, subject to
                subparagraph (B).
                    ``(B) Timing of deemed interchangeability.--
                            ``(i) Licensure on or after transition
                        date.--A biological product licensed under this
                        subsection on or after the transition date
                        described in subparagraph (C) (referred to in
                        this clause as the `applicable biological
                        product') shall be deemed to be interchangeable
                        with the reference product upon such licensure,
                        unless the applicable biological product relied
                        on the same reference product as another
                        biological product for which--
                                    ``(I) licensure under this
                                subsection was in effect on the date of
                                enactment of the Biosimilar Red Tape
                                Elimination Act; and
                                    ``(II) a first interchangeable
                                exclusivity period under paragraph (6)
                                (as in effect on the date of enactment
                                of the Biosimilar Red Tape Elimination
                                Act) is in effect on the date of
                                licensure of the applicable biological
                                product,
                        in which case the applicable biological product
                        shall be deemed interchangeable with the
                        reference product under this paragraph on the
                        date on which the exclusivity period described
                        in subclause (II) ends.
                            ``(ii) Licensure prior to transition
                        date.--A biological product licensed under this
                        subsection prior to the transition date
                        described in subparagraph (C) (referred to in
                        this clause as the `applicable biological
                        product') shall be deemed to be interchangeable
                        with the reference product on such transition
                        date, unless the applicable biological product
                        relied on the same reference product as another
                        biological product for which--
                                    ``(I) licensure under this
                                subsection was in effect on the date of
                                enactment of the Biosimilar Red Tape
                                Elimination Act; and
                                    ``(II) a first interchangeable
                                exclusivity period under paragraph (6)
                                (as in effect on the date of enactment
                                of the Biosimilar Red Tape Elimination
                                Act) is in effect on the transition
                                date,
                        in which case the applicable biological product
                        shall be deemed interchangeable with the
                        reference product under this paragraph on the
                        date on which the exclusivity period described
                        in subclause (II) ends.
                    ``(C) Transition date.--The transition date
                described in this subparagraph is the date that is 60
                days after the date of enactment of the Biosimilar Red
                Tape Elimination Act.'';
            (5) by amending paragraph (6) to read as follows:
            ``(6) Transition with respect to preserving first
        interchangeability exclusivity with respect to certain
        biological products.--With respect to a biological product
        licensed under this subsection before the date of enactment of
        the Biosimilar Red Tape Elimination Act, for which there was an
        unexpired period of first interchangeable exclusivity under
        this subsection (as then in effect), such unexpired exclusivity
        period shall remain in effect for the duration of such
        period.''; and
            (6) in paragraph (8)(D)--
                    (A) in clause (i), by striking ``class; and'' and
                inserting ``class.'';
                    (B) by striking clause (ii); and
                    (C) by striking ``description of--'' and all that
                follows through ``criteria that the Secretary'' and
                inserting ``description of the criteria that the
                Secretary''.
    (b) Conforming Amendments.--
            (1) Section 351(i)(3) of the Public Health Service Act (42
        U.S.C. 262(i)(3)) is amended by striking ``that is shown to
        meet the standards described in subsection (k)(4)'' and
        inserting ``licensed under subsection (k)''.
            (2) Section 352A of the Public Health Service Act (42
        U.S.C. 263-1) is amended by striking ``and interchangeable
        biosimilar biological products'' each place it appears.
            (3) Section 744G(14) of the Federal Food, Drug, and
        Cosmetic Act (21 U.S.C. 379j-51(14)) is amended by striking ``,
        including a supplement requesting that the Secretary determine
        that the biosimilar biological product meets the standards for
        interchangeability described in section 351(k)(4) of the Public
        Health Service Act''.
            (4) By amending subsection (l) of section 505B of the
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) to read
        as follows:
    ``(l) Biosimilar Biological Products.--A biological product for
which an application is submitted under section 351(k) of the Public
Health Service Act shall not be considered to have a new active
ingredient for purposes of this section, unless the application seeks
licensure for--
            ``(1) a claimed indication that has been approved for the
        reference product in a relevant pediatric population or for
        which there is a deferral of the pediatric assessment under
        paragraph (4) for the reference product; and
            ``(2) the assessment would not involve the development of a
        biological product with a strength, dosage form, route of
        administration, or condition of use that could not be licensed
        under section 351(k) of the Public Health Service Act.''.
    (c) Guidance.--The Secretary shall--
            (1) not later than 18 months after the date of enactment of
        this Act, update existing draft and final guidance to reflect
        the amendments made by this Act, including by revising or
        revoking the guidance document titled ``Considerations in
        Demonstrating Interchangeability With a Reference Product''
        (May 2019) and ``Considerations in Demonstrating
        Interchangeability With a Reference Product: Update'' (June
        2024);
            (2) not later than 18 months after the date of enactment of
        this Act, issue or revise guidance on review and approval of
        biosimilar biological products under section 351(k) of the
        Public Health Service Act (42 U.S.C. 262(k)) relating to the
        data and information that an applicant is required to submit to
        support a determination that a biosimilar biological product
        that is the subject of an application under such section is
        biosimilar to the reference product (as defined in section
        351(i) of such Act (42 U.S.C. 262(i))); and
            (3) not later than 18 months after the comment period
        closes on the guidance under paragraphs (1) and (2), issue
        revised draft or final versions of such guidances.
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