[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1954 Reported in Senate (RS)]
<DOC>
Calendar No. 521
119th CONGRESS
2d 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, Ms. Hassan, Mr. Schmitt, and
Mr. Ossoff) introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
July 27, 2026
Reported by Mr. Cassidy, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
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,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Biosimilar Red Tape
Elimination Act''.</DELETED>
<DELETED>SEC. 2. BIOSIMILAR BIOLOGICAL PRODUCTS.</DELETED>
<DELETED> (a) In General.--Section 351(k) of the Public Health
Service Act (42 U.S.C. 262(k)) is amended--</DELETED>
<DELETED> (1) in the subsection heading, by striking ``or
Interchangeable'';</DELETED>
<DELETED> (2) in paragraph (2)--</DELETED>
<DELETED> (A) by striking subparagraph
(B);</DELETED>
<DELETED> (B) by redesignating clauses (ii) and
(iii) of subparagraph (A) as subparagraphs (B) and (C),
respectively, and adjusting the margins
accordingly;</DELETED>
<DELETED> (C) in subparagraph (A)--</DELETED>
<DELETED> (i) in clause (i), by
redesignating subclauses (I) through (V) as
clauses (i) through (v), respectively, and
adjusting the margins accordingly;</DELETED>
<DELETED> (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</DELETED>
<DELETED> (iii) by striking ``(a) in
general'' and all that follows through ``An
application submitted under this subsection
shall include information'' and inserting the
following:</DELETED>
<DELETED> ``(A) In general.--An application
submitted under this subsection shall include
information'';</DELETED>
<DELETED> (D) in subparagraph (B), as so
redesignated by subparagraph (B) of this paragraph, by
striking ``clause (i)(I)'' and inserting ``subparagraph
(A)(i)''; and</DELETED>
<DELETED> (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;</DELETED>
<DELETED> (3) by amending subparagraph (A) of paragraph (3)
to read as follows:</DELETED>
<DELETED> ``(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'';</DELETED>
<DELETED> (4) by amending paragraph (4) to read as
follows:</DELETED>
<DELETED> ``(4) Interchangeability.--</DELETED>
<DELETED> ``(A) In general.--A biological product
licensed under this subsection shall be deemed to be
interchangeable with the reference product, subject to
subparagraph (B).</DELETED>
<DELETED> ``(B) Timing of deemed
interchangeability.--</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(I) licensure under this
subsection was in effect on the date of
enactment of the Biosimilar Red Tape
Elimination Act; and</DELETED>
<DELETED> ``(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,</DELETED>
<DELETED>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.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(I) licensure under this
subsection was in effect on the date of
enactment of the Biosimilar Red Tape
Elimination Act; and</DELETED>
<DELETED> ``(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,</DELETED>
<DELETED>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.</DELETED>
<DELETED> ``(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.'';</DELETED>
<DELETED> (5) by amending paragraph (6) to read as
follows:</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (6) in paragraph (8)(D)--</DELETED>
<DELETED> (A) in clause (i), by striking ``class;
and'' and inserting ``class.'';</DELETED>
<DELETED> (B) by striking clause (ii); and</DELETED>
<DELETED> (C) by striking ``description of--'' and
all that follows through ``criteria that the
Secretary'' and inserting ``description of the criteria
that the Secretary''.</DELETED>
<DELETED> (b) Conforming Amendments.--</DELETED>
<DELETED> (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)''.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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''.</DELETED>
<DELETED> (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:</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED> (c) Guidance.--The Secretary shall--</DELETED>
<DELETED> (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);</DELETED>
<DELETED> (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</DELETED>
<DELETED> (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.</DELETED>
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;
(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''; and
(iv) in clause (i)(II), as so redesignated
by clauses (i) and (ii) of this subparagraph,
by striking ``item (aa) or (cc)'' and inserting
``subclause (I) or (III)'';
(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--
(i) by redesignating subclauses (I) through
(III) as clauses (i) through (iii),
respectively, and adjusting the margins
accordingly; and
(ii) by striking ``publicly-available''
each place it appears and inserting ``publicly
available'';
(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.--A
biological product licensed under this subsection
(referred to in this subparagraph as the `applicable
biological product') shall be deemed to be
interchangeable with the reference product upon such
licensure (or, in the case of a biological product so
licensed before the transition date described in
subparagraph (C), 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
day before the date of enactment of the
Biosimilar Red Tape Elimination Act) is in
effect on the date of licensure of the
applicable biological product (or on the
transition date described in subparagraph (C),
in the case of a biological product licensed
before 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 clause (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 of the Public Health Service Act (42 U.S.C.
262) is amended--
(A) in subsection (i)(3), by striking ``that is
shown to meet the standards described in subsection
(k)(4)'' and inserting ``licensed under subsection
(k)''; and
(B) in subsection (l)(1)(F), by striking
``publicly-available'' and inserting ``publicly
available''.
(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) Subsection (l) of section 505B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355c) is amended to read as
follows:
``(l) Biosimilar Biological Products.--A biological product for
which an application, including a supplement to 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--
``(1) the application seeks licensure for 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 subsection (a)(4)
for the reference product; and
``(2) the assessment or investigation described in
subsection (a) 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 such section 351(k).''.
(c) Guidance.--The Secretary of Health and Human Services may issue
or revise guidance, as appropriate, regarding the data and information
that an applicant may be required to submit to support a determination
of biosimilarity in an application submitted under section 351(k) of
the Public Health Service Act (42 U.S.C. 262(k)), as amended by this
Act, including any additional information related to the device
constituent part of a biosimilar biological product that is a
combination product. The issuance or non-issuance of such guidance
shall not preclude the review of, or action on, an application
submitted under section 351(k) of the Public Health Service Act (42
U.S.C. 262(k)), as amended by this Act.
Calendar No. 521
119th CONGRESS
2d Session
S. 1954
_______________________________________________________________________
A BILL
To improve the requirements for making a determination of
interchangeability of a biological product and its reference product.
_______________________________________________________________________
July 27, 2026
Reported with an amendment