S. 1414 · 119th Congress — Expedited Access to Biosimilars Act
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…
- Congress
- 119
- Bill
- S 1414
- Status
- In Progress
- Introduced
- 2025-04-10
- Latest action date
- 2026-07-27
Record overview
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.
Latest action
Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.
Sponsors
- Sen. Paul, Rand [R-KY]
Kentucky · Senate · Republican
Record provenance
Stored record updated: 2026-09-14. This is separate from the action date and does not establish enactment.