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Expedited Access to Biosimilars Act
To amend the Public Health Service Act to provide that clinical studies required for licensure of biological products as biosimilar shall not be required to include the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy.
Summary
- Removes the requirement that clinical studies for biosimilar licensing assess immunogenicity, pharmacodynamics, or comparative clinical efficacy
- Requires clinical studies to demonstrate only pharmacokinetics and safety, purity, and potency in appropriate conditions of use
- Gives the FDA Secretary discretion to require immunogenicity, pharmacodynamics, or comparative clinical efficacy assessments on a case-by-case basis
- Requires the FDA to provide written justification to applicants if it determines additional assessments are necessary
- Applies to biosimilar applications submitted on or after the bill's enactment date
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
- Sen. Paul, Rand [R-KY] (R-KY)
2 cosponsors
- Sen. Hassan, Margaret Wood [D-NH] (D-NH)
- Sen. Lee, Mike [R-UT] (R-UT)
Actions (3)
- Jul 22, 2026 Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. · senate
- Apr 10, 2025 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. · senate
- Apr 10, 2025 Introduced in Senate
Similar bills (6)
Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.
Committee action
What happened to this bill in committee — the meetings where it was considered and every recorded vote taken on it.
Meetings where this bill was on the agenda
Full text
IN THE SENATE OF THE UNITED STATES
April 10, 2025
Mr. Paul introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
A BILL
To amend the Public Health Service Act to provide that clinical studies required for licensure of biological products as biosimilar shall not be required to include the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy.
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 “Expedited Access to Biosimilars Act”.
SEC. 2. ASSESSMENT OF IMMUNOGENICITY, PHARMACODYNAMICS, OR COMPARATIVE CLINICAL EFFICACY IN CLINICAL STUDIES REQUIRED FOR LICENSURE OF BIOLOGICAL PRODUCTS AS BIOSIMILAR.
(a) In General.—Section 351(k)(2)(A) of the Public Health Service Act (42 U.S.C. 262(k)(2)(A)) is amended—
(1) in clause (i)(I)—
(A) in item (bb), by striking “and” at the end; and
(B) by striking item (cc) and inserting the following
“(cc) a clinical study or studies assessing pharmacokinetics that are sufficient to demonstrate safety, purity, and potency; and
“(dd) subject to clause
(iv), a clinical study or studies that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product;”; and
(2) by adding at the end the following:
“(iv) Clinical studies.—
“(I) In general.—Subject to subclause (II), the Secretary may determine, in the Secretary’s discretion, that a clinical study required under clause (i)(I)(dd) shall include the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy.
“(II) Requirement.—The Secretary may only require the assessment of immunogenicity, pharmacodynamics, or comparative clinical efficacy pursuant to a determination under subclause (I) if the Secretary provides to the applicant notice of the requirement, including a written justification of the basis for such determination, not later than the earliest date on which the applicant may file the application under this subsection.”.
(b) Applicability.—The amendments made by subsection (a) shall apply with respect to an application submitted under section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)) on or after the date of enactment of this Act. <all>
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