Biosimilar Red Tape Elimination Act

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.

119 S1954 RS: Biosimilar Red Tape Elimination Act U.S. Senate 2026-07-27 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. IICalendar No. 521119th CONGRESS2d SessionS. 1954IN THE SENATE OF THE UNITED STATESJune 4, 2025Mr. Lee (for himself, Mr. Luján, 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 PensionsJuly 27, 2026Reported by Mr. Cassidy, with an amendmentStrike out all after the enacting clause and insert the part printed in italicA BILLTo improve the requirements for making a determination of interchangeability of a biological product and its reference product.1.Short titleThis Act may be cited as the Biosimilar Red Tape Elimination Act.2.Biosimilar biological products(a)In generalSection 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 generalAn 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 generalA 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 dateA 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 dateA 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 dateThe 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 productsWith 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 productsA 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)GuidanceThe 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.1.Short titleThis Act may be cited as the Biosimilar Red Tape Elimination Act.2.Biosimilar biological products(a)In generalSection 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 generalAn 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 generalA biological product licensed under this subsection shall be deemed to be interchangeable with the reference product, subject to subparagraph (B).(B)Timing of deemed interchangeabilityA 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 dateThe 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 productsWith 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 productsA 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)GuidanceThe 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.July 27, 2026Reported with an amendment