S. 1954

119 S1954 IS: Biosimilar Red Tape Elimination Act
 U.S. Senate
 2025-06-04
 text/xml
 EN
 Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
  II
  119th CONGRESS
  1st Session
  S. 1954
  IN THE SENATE OF THE UNITED STATES
  June 4, 2025
  Mr. Lee  (for himself,  Mr. Luján ,  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.
1.
Short title
This Act may be cited as the   Biosimilar Red Tape Elimination Act  .
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.