Expedited Access to Biosimilars Act

Rand Paul

Republican · KY · Senator

Source: Congress.gov · FEC

• Mike Lee (R-UT)· 2025-06-03
• Margaret Wood Hassan (D-NH)· 2026-07-20

Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.

2026-07-27

Source: Congress.gov

Expedited Access to Biosimilars Act This bill modifies statutory requirements for demonstrating that a proposed biological product (e.g., a drug or vaccine) is biosimilar to a reference (brand-name) product. Specifically, the bill eliminates the need for a clinical efficacy study unless the Food and Drug Administration (FDA) determines such a study is necessary. Under current law, applicants seeking FDA approval of a proposed biosimilar must submit certain studies and assessments, including a clinical efficacy study demonstrating the safety, purity, and potency of the proposed biosimilar in relevant conditions of use. However, the FDA has discretion not to require studies and assessments it deems unnecessary. (For example, the FDA released draft guidance in October 2025 indicating that clinical efficacy studies may be unnecessary for a class of proposed biosimilars, known as therapeutic protein products, in some circumstances.) The bill generally eliminates the requirement that a biosimilar applicant submit a clinical efficacy study but authorizes the FDA to require such a study if necessary. If requiring a clinical efficacy study, the FDA must provide a written determination of necessity to the applicant within a specified period. Separately, the bill eliminates a requirement that a biosimilar application be reviewed by the same FDA division responsible for review of the reference application.

Plain-English rewrite of the Congressional Research Service summary published on Congress.gov. Cached and reviewed.

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [S. 1414 Introduced in Senate (IS)] <DOC> 119th CONGRESS 1st Session S. 1414 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. _______________________________________________________________________ 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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