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S. 1414 119th Congress Senate

Expedited Access to Biosimilars Act

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 require… Show full official titleShow less

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.

Introduced: April 10, 2025 Introduced by: Rand Paul Republican · Kentucky See on congress.gov
Health Drug safety, medical device, and laboratory regulationLicensing and registrationsMedical research
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 Everywhere this bill has been 5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 27, 2026
Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.
Jul 27, 2026
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
Jul 22, 2026
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Apr 10, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Apr 10, 2025
Introduced in Senate
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What's happening now July 27, 2026

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

 Plain-English summary Congressional Research Service

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 (For example, the FDA released draft guidance in October 2025 indicating that clinical efficacy studies may be unnecessary for a class of proposed biosimilars, known as therapeutic protein products, in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

 Hearings & markups 1
 Related & companion bills 1
  • S 5059 A bill to amend the Public Health Service Act to streamline the review of biosimilar biological products.
 Bill text 2 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Lobbying activity 64

Registered lobbyists who named this bill in their disclosure filings. Source: federal Lobbying Disclosure Act filings.

Bodies those filers lobbied

A filing lists the bills it worked on and the parts of government it contacted in separate sections, so these are the bodies those filers named anywhere in the filing, not a per-bill breakdown.

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 Cosponsors 2
All 2 Democratic 1 Republican 1
D
Hassan, Margaret Wood
New Hampshire · Jul 20, 2026
 R
Lee, Mike
Utah · Jun 3, 2025
Cite this page click to expand
APA
U.S. Congress. (2026). S. 1414: Expedited Access to Biosimilars Act. 119th Congress. Open America. https://openamerica.io/bill/119-S-1414/
MLA
"S. 1414: Expedited Access to Biosimilars Act." 119th Congress, 2026, Open America, https://openamerica.io/bill/119-S-1414/.
Bluebook (legal)
S. 1414, 119th Cong. (2026), https://openamerica.io/bill/119-S-1414/.
Markdown link
[S. 1414: Expedited Access to Biosimilars Act](https://openamerica.io/bill/119-S-1414/)
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