Expedited Access to Biosimilars Act

Nicholas A. Langworthy

Republican · NY · Representative

Source: Congress.gov · FEC

• Kim Schrier (D-WA-8)Original· 2026-07-14

Referred to the House Committee on Energy and Commerce.

2026-07-14

Source: Congress.gov

The bill would change the rules for approving generic versions of complex biological drugs (called biosimilars) by making it the standard expectation that companies don't need to conduct expensive clinical studies comparing how well these drugs work compared to the original drug. This would likely make it faster and cheaper for biosimilar manufacturers to get their products approved, potentially lowering costs for patients and insurance companies, though it could raise questions about whether the drugs are truly equivalent to the originals.

AI-assisted summary generated from the official bill metadata (title, subjects, actions) sourced from Congress.gov. Cached and reviewed. Always verify against the official text linked below.

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 9661 Introduced in House (IH)] <DOC> 119th CONGRESS 2d Session H. R. 9661 To amend the Public Health Service Act to codify that the default expectation for licensure of biological products as biosimilar does not include clinical studies assessing pharmacodynamics or comparative clinical efficacy, and for other purposes. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES July 14, 2026 Mr. Langworthy (for himself and Ms. Schrier) introduced the following bill; which was referred to the Committee on Energy and Commerce _______________________________________________________________________ A BILL To amend the Public Health Service Act to codify that the default expectation for licensure of biological products as biosimilar does not include clinical studies assessing pharmacodynamics or comparative clinical efficacy, and for other purposes. 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 PHARMACODYNAMICS OR 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)-- (i) by striking ``item (aa) or (cc)'' and inserting ``item (aa), (cc), or (dd)''; and (ii) by striking ``and'' at the end; and (B) by striking item (cc) and inserting the following: ``(cc) an assessment of pharmacokinetics and immunogenicity (which may rely on, or consist of, a clinical pharmacokinetics study or studies or a study or studies described in item (aa) or (dd), as appropriate); and ``(dd) subject to clause (iv), an additional clinical study or studies 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) Limitation on requiring additional clinical study or studies.--The Secretary may only require an additional clinical study or studies described in clause (i)(I)(dd), including a study or studies that include an assessment of pharmacodynamics or efficacy, if the Secretary determines that such study or studies are necessary, in combination with the other studies described in clause (i)(I), to demonstrate biosimilarity and provides written notice of such determination to the sponsor of the proposed biosimilar biological product. Such written notice shall be provided not later than-- ``(I) the date on which the Secretary grants a request for a biosimilar biological product development meeting from such sponsor, unless the Secretary describes in writing why an assessment of the need for such study or studies cannot be made at that time; or ``(II) if no request for a biosimilar biological product development meeting is submitted or if the Secretary was unable to make the assessment under subclause (I), the date that is 60 days after the date of the submission of an application under this subsection.''. (b) Repeal of Requirement Relating To Conduct of Reviews.--Section 351(k)(5) of the Public Health Service Act (42 U.S.C. 262(k)(5)) is amended-- (1) by striking subparagraph (B); and (2) by redesignating subparagraph (C) as subparagraph (B). (c) 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>

• HR5517Northern Border Security Enhancement and Review Act
  Reported by Committee · 2026-06-24
• HR9317BUSES Act
  Referred to Committee · 2026-06-15
• HRES1345Providing for consideration of the bill (H.R. 8312) to establish fraud prevention and program integrity functions and data sharing authorities within the Department of Treasury and a permanent governmentwide Inspector General for Fraud, Accountability, and Recovery, and for other purposes; providing for consideration of the bill (H.R. 8464) to amend title 31, United States Code, to authorize pausing and segmenting payments, and for other purposes; providing for consideration of the resolution (H. Res. 1335) condemning actors seeking to defraud the United States Government, and expressing the sense of the House of Representatives that governmentwide fraud and improper payment prevention reforms will meaningfully improve the financial prosperity of the United States, and that Federal program eligibility should be verified before payment; and providing for consideration of the bill (S. 2) to provide for reconciliation pursuant to title II of S. Con. Res. 33.
  Passed House · 2026-06-09
• HR9117To promote the availability of certain healthcare information, and for other purposes.
  Referred to Committee · 2026-06-03