Expedited Access to Biosimilars Act
The source supplies the latest action, but no lifecycle stage.
Latest action (27 Jul 2026): Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.
What this bill does
The Expedited Access to Biosimilars Act would change the requirements for approving biosimilar biological products, which are similar to existing brand-name drugs. Currently, companies seeking approval must generally include studies showing the biosimilar's safety, purity, potency, and clinical efficacy. This bill would eliminate the automatic requirement for a clinical efficacy study, though the Food and Drug Administration (FDA) could still require one if it determines it is necessary and provides a written justification. The bill also removes a rule that a biosimilar application must be reviewed by the same FDA division that reviewed the original brand-name drug.
This legislation primarily affects companies that develop and seek FDA approval for biosimilar biological products. By potentially reducing the need for certain studies, it aims to make the approval process faster. The bill has passed through the Senate Committee on Health, Education, Labor, and Pensions, and has been ordered reported with an amendment. Its next step would be consideration by the full Senate.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Official 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 (For example, the FDA released draft guidance in October 2025 indicating that clinical efficacy studies may be unnecessary for a class of proposed biosimilars, known as therapeutic protein products, in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.
Timeline
27 Jul 2026
Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.
Common questions
- What does S. 1414 do?
- The Expedited Access to Biosimilars Act would change the requirements for approving biosimilar biological products, which are similar to existing brand-name drugs. Currently, companies seeking approval must generally include studies showing the biosimilar's safety, purity, potency, and clinical efficacy. This bill would eliminate the automatic requirement for a clinical efficacy study, though the Food and Drug Administration (FDA) could still require one if it determines it is necessary and provides a written justification. The bill also removes a rule that a biosimilar application must be reviewed by the same FDA division that reviewed the original brand-name drug. This legislation primarily affects companies that develop and seek FDA approval for biosimilar biological products. By potentially reducing the need for certain studies, it aims to make the approval process faster. The bill has passed through the Senate Committee on Health, Education, Labor, and Pensions, and has been ordered reported with an amendment. Its next step would be consideration by the full Senate.
- Has S. 1414 become law?
- The source does not supply a confirmed lifecycle stage for S. 1414. Check the latest action and official source below.
- Who sponsored S. 1414?
- S. 1414 was sponsored by Sen. Paul, Rand [R-KY] (R-KY), with 2 cosponsors.
- What's the latest action on S. 1414?
- Placed on Senate Legislative Calendar under General Orders. Calendar No. 520. (27 Jul 2026).
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