Expedited Access to Biosimilars Act

Summary

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 (For example, the FDA released draft guidance in October 2025 indicating that clinical efficacy studies may be unnecessary for a class of proposed biosimilars, known as therapeutic protein products, in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

Summary from the Congressional Research Service. How we handle summaries

Where it stands

Out of committee and scheduled for a vote by the full chamber.

Senate Committee on Health, Education, Labor, and Pensions · U.S. Senate

Your position on this bill

Choose the position closest to yours. You'll sign in or create an account to save it.

Cosponsors

Full history

1. Jul 27, 2026

   Reported out of committee

   Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.

2. Jul 27, 2026

   Reported out of committee

   Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.

3. Jul 27, 2026

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

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

   U.S. Senate

4. Jul 27, 2026

   Introduced

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

   U.S. Senate

5. Jul 22, 2026

   Reported out of committee

   Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.

Read the record

• Read on Congress.gov (opens in a new tab) The official record on Congress.gov.