HR 5526
Biosimilar Red Tape Elimination Act
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Bill overview
The Biosimilar Red Tape Elimination Act aims to streamline the process for approving biosimilar biological products. It modifies existing regulations to simplify the requirements for determining if a biosimilar is interchangeable with its reference product, reducing potential barriers to market entry. Specifically, it clarifies the data needed for licensure and establishes a transition period for existing biosimilar applications, and updates guidance documents to reflect these changes. The bill also ensures that unexpired first interchangeable exclusivity periods for previously licensed biosimilars are preserved.
Key provisions
- Clarifies the criteria for determining biosimilarity between a biological product and its reference product.
- Establishes a ‘transition date’ (60 days after enactment) for determining interchangeability of biosimilars.
- Defines a process for preserving existing first interchangeable exclusivity periods.
- Updates guidance documents related to biosimilar licensure and interchangeability.
- Modifies regulations regarding new active ingredients for biosimilar products.
- Conforms existing regulations to align with the changes made to section 351(k) of the Public Health Service Act.
- Addresses the definition of ‘interchangeable’ within the context of biosimilar licensure.
- Specifies a timeline for the Secretary to update guidance documents.
Who is affected
- Biopharmaceutical companies developing biosimilar products
- Healthcare providers
- Patients
- The pharmaceutical industry
Sponsors
Official sponsors from legislative records.
Primary sponsor
Cosponsors
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119th CONGRESS — 1st Session
H. R. 5526
IN THE HOUSE OF REPRESENTATIVES
A BILL
To improve the requirements for making a determination of interchangeability of a biological product and its reference product.
This Act may be cited as the Biosimilar Red Tape Elimination Act
.
in the subsection heading, by striking or interchangeable
;
in paragraph (2)—
by striking subparagraph (B);
by redesignating clauses (ii) and (iii) of subparagraph (A) as subparagraphs (B) and (C), respectively, and adjusting the margins accordingly;
in subparagraph (A)—
in clause (i), by redesignating subclauses (I) through (V) as clauses (i) through (v), respectively, and adjusting the margins accordingly;
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;
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
by striking (A) In General
and all that follows through An application submitted under this subsection shall include information
and inserting the following:
An application submitted under this subsection shall include information
in subparagraph (B), as so redesignated by subparagraph (B) of this paragraph, by striking clause (i)(I)
and inserting subparagraph (A)(i)
; and
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;
by amending subparagraph (A) of paragraph (3) to read as follows:
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
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—
Biosimilar Red Tape Elimination Act
; andBiosimilar 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.
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—
Biosimilar Red Tape Elimination Act
; andBiosimilar 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.
Biosimilar Red Tape Elimination Act
.by amending paragraph (6) to read as follows:
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.in paragraph (8)(D)—
in clause (i), by striking class; and
and inserting class.
;
by striking clause (ii); and
by striking description of—
and all that follows through criteria that the Secretary
and inserting description of the criteria that the Secretary
.
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)
.
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.
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
.
Section 505B(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(l)) to read as follows:
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—
The Secretary shall—
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);
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
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.
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