S. 1414 · 119th Congress

Expedited Access to Biosimilars Act

Introduced on Apr 10, 2025 by Rand Paul (R-KY). 2 cosponsors, 1 of them from another party. Latest action (Jul 27, 2026): Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.

Stage
Reported by committee
Introduced
Apr 10, 2025
Cosponsors
2
1 from the other party
Policy area
Health
Open in the Congress explorerCongress.govAlert me

Progress

The furthest stage the measure reached. Simple and concurrent resolutions do not go to the President.

  1. Introduced
  2. Reported by committee
  3. 3Passed one chamber
  4. 4Passed both chambers
  5. 5Sent to the President
  6. 6Became law

Official title

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.

Subjects

  • Drug safety, medical device, and laboratory regulation
  • Licensing and registrations
  • Medical research

Summary

By the Congressional Research Service (Reported to Senate, Jul 27, 2026). Public domain.

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 (For example, the FDA released draft guidance in October 2025 indicating that clinical efficacy studies may be unnecessary for a class of proposed biosimilars, known as therapeutic protein products, in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.

Sponsor and cosponsors

Cosponsors by party as of the day they signed on. Original cosponsors signed on the day of introduction.

Rand PaulR-KYSponsor

Democrats · 1

Republicans · 1

Roll calls

Recorded votes on the measure. Most measures move by voice vote or unanimous consent, which record no individual positions.

No recorded roll call on this measure: it moved by voice vote or unanimous consent, or has not reached the floor.

History

Every action as published, oldest first. Roll calls link to how each member voted.

  1. Apr 10, 2025Introduced in Senate
  2. Apr 10, 2025 · SenateRead twice and referred to the Committee on Health, Education, Labor, and Pensions.
  3. Jul 22, 2026 · SenateCommittee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
  4. Jul 27, 2026Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
  5. Jul 27, 2026 · SenateCommittee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
  6. Jul 27, 2026 · SenatePlaced on Senate Legislative Calendar under General Orders. Calendar No. 520.

Committees

Committees and subcommittees the measure was referred to.

Agencies in its committees' jurisdiction

Analisa's mapping of committee jurisdiction to federal agencies; the bill may touch others, or none of these.

Who lobbied on it

Organizations whose lobbying reports (LD-2) name this measure. Spending is what they reported for those quarters on all issues, not on this measure alone.

  1. PHARMACEUTICAL RESEARCH & MANUFACTURERS OF AMERICA10 reports
    $44.6M reported (all issues)
  2. AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP)5 reports
    $20.7M reported (all issues)
  3. ASSOCIATION FOR ACCESSIBLE MEDICINES5 reports
    $4.2M reported (all issues)
  4. Association of Accessible Medicines (formerly known as GPhA)5 reports
    $300K reported (all issues)
  5. GSK (fka GLAXOSMITHKLINE INC.)5 reports
    $6.6M reported (all issues)
  6. PHARMACEUTICAL CARE MANAGEMENT ASSOCIATION4 reports
    $12.7M reported (all issues)
  7. Fresenius Kabi USA LLC3 reports
    $1.4M reported (all issues)Federal contractor: FRESENIUS KABI USA, LLCAI match · 100%
  8. Campaign for Sustainable Drug Pricing (CSRxP)2 reports
    $100K reported (all issues)
  9. KAISER FOUNDATION HEALTH PLAN INC.2 reports
    $3.5M reported (all issues)Federal contractor: KAISER FOUNDATION HEALTH PLAN OF WASHINGTONAI match · 97%
  10. The Campaign for Sustainable Rx Pricing2 reports
    $180K reported (all issues)
  11. AMGEN INC.1 report
    $2.4M reported (all issues)Federal contractor: AMGEN INC.AI match · 99%
  12. BIOTECHNOLOGY INNOVATION ORGANIZATION1 report
    $2.4M reported (all issues)
  13. Pharmaceutical Industry Labor-Management Association1 report
    $60K reported (all issues)

Reports filed in 2025, 2026.

Sources and method

Every figure on this page traces to these records.

  • Bill status: bills and resolutions, sponsors, actions, subjects and CRS summaries (U.S. Government Publishing Office (GovInfo), from Congress.gov (Library of Congress))GovInfo Bill Status bulk data (Congress.gov; summaries by the Congressional Research Service) · data current to Oct 9, 2026 · loaded Oct 9, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Members of Congress, their terms, committees and identifiers (The @unitedstates project (from the Biographical Directory of the U.S. Congress, the House and the Senate))unitedstates/congress-legislators: legislators, committees and current committee membership · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: CC0 1.0 (public domain dedication)
  • House roll-call votes (Office of the Clerk, U.S. House of Representatives)Office of the Clerk, U.S. House of Representatives, roll-call vote records · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Senate roll-call votes and DW-NOMINATE scores (Voteview (UCLA Department of Political Science))Lewis, Jeffrey B., Keith Poole, Howard Rosenthal, Adam Boche, Aaron Rudkin, and Luke Sonnet (2026). Voteview: Congressional Roll-Call Votes Database. https://voteview.com/ · data current to Oct 3, 2026 · loaded Oct 3, 2026 · license: Free to use with the required citation
  • Lobbying disclosures (LD-1 registrations, LD-2 quarterly reports, LD-203 contribution reports) (Clerk of the U.S. House of Representatives)Clerk of the House, Lobbying Disclosure Act filings (organizations only; lobbyists' names are not loaded) · data current to Oct 9, 2026 · loaded Oct 9, 2026 · license: Public domain (U.S. Government work, 17 U.S.C. § 105)
  • Positions are shown only where a roll call recorded them; voice votes and unanimous consent record none.
  • Money and votes are shown side by side; neither explains the other.