S 1414 119th Congress
Expedited Access to Biosimilars Act
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.
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Bill journey
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Introduction Congress.gov
Introduced
Introduced in the Senate.
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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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Introduced in Senate
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Introduced in Senate
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Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
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Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.
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Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
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Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
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Reported to Senate
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View the complete bill journey as an accessible table
| Date and time | Record | Official detail | Source |
|---|---|---|---|
| IntroductionIntroduced | Introduced in the Senate. | Congress.gov | |
| Official actionRead twice and referred to the Committee on Health, Education, Labor, and Pensions. | No additional detail supplied.IntroReferral · Senate | Congress.gov | |
| Official actionIntroduced in Senate | No additional detail supplied.IntroReferral · Library of Congress · Code 10000 | Congress.gov | |
| Text versionIntroduced in Senate | A dated text-version record is available. | Congress.gov | |
| Official actionCommittee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. | No additional detail supplied.Committee · Senate | Congress.gov | |
| Official actionPlaced on Senate Legislative Calendar under General Orders. Calendar No. 520. | No additional detail supplied.Calendars · Senate | Congress.gov | |
| Official actionCommittee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report. | No additional detail supplied.Committee · Senate | Congress.gov | |
| Official actionCommittee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report. | No additional detail supplied.Committee · Library of Congress · Code 14000 | Congress.gov | |
| Text versionReported to Senate | A dated text-version record is available. | Congress.gov |
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Congressional Research Service
CRS summary
Expedited Access to Biosimilars ActThis 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.
Official documents
Text versions
- Reported to SenateJul 27, 2026
- Introduced in SenateApr 10, 2025