119-hr5526

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5526 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 5526

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

_______________________________________________________________________

 IN THE HOUSE OF REPRESENTATIVES

 September 19, 2025

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

_______________________________________________________________________

 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;
            (iii) in subclause
            (II) of clause
            (i) , as 
 so redesignated by clause
            (ii) of this 
 subparagraph, by striking ``item

    (aa) or
            (cc) '' 
 and inserting ``subclause
            (I) or
            (III) ''; and
            (iv) 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 day 
 before 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,
 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 day 
 before 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 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 
 interchangeable 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) Section 505B
            (l) of the Federal Food, Drug, and Cosmetic 
 Act (21 U.S.C. 355c
            (l) ) 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.
            (d) Rules of Construction.--The amendments made by this section 
shall not be construed--

    (1) to alter the standard or the information required for 
 licensure of a biological product as biosimilar to a reference 
 product pursuant to 

section 351

    (k) of the Public Health Service 
 Act (42 U.S.C. 262

    (k) ); or

    (2) to limit the information that may be required by the 
 Secretary of Health and Human Services to support the licensure 
 of a biological product as biosimilar to a reference product 
 pursuant to such section.
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