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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1954 Introduced in Senate (IS)]
<DOC>
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.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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