# 119-s-1414: Expedited Access to Biosimilars Act

119-s-1414, Expedited Access to Biosimilars Act, is a 119th Congress bill sponsored by Sen. Paul, Rand [R-KY] (R-KY); status in_committee; PRIA reads it as touching household money (as of 2026-09-16).

- Canonical: https://policyrisk.com/legislation/119-s-1414
- As of: 2026-09-16
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-s-1414
- Congress: 119
- Title: Expedited Access to Biosimilars Act
- Status: in_committee
- Introduced: 2025-04-10
- Sponsor: Sen. Paul, Rand [R-KY] (R-KY)
- Cosponsors: 2
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-09-16

## Summary

**Creates a time‑bound framework for when regulators can require additional clinical data for biosimilars.** This bill would define what extra data may be required and add specific procedural protections for sponsors.

## Cosponsors (2)

- Sen. Lee, Mike [R-UT] (R-UT), 2025-06-03T00:00:00.000Z
- Sen. Hassan, Margaret Wood [D-NH] (D-NH), 2026-07-20T00:00:00.000Z

## Provisions PRIA read

- Clearer rules for biosimilar approvals: benefit, low. If enacted, this bill would change FDA rules for biosimilar drug approvals. Sponsors would need an assessment of pharmacokinetics and immunogenicity. The FDA would be able to require extra clinical studies that test pharmacodynamics or comparative efficacy only after giving a written determination…

## Related bills

- 119-s-1954: Biosimilar Red Tape Elimination Act
- 119-s-1302: Increasing Transparency in Generic Drug Applications Act
- 119-sres-913: A resolution relating to the death of the Honorable Nancy Kassebaum, former United States Senator for the State of Kansas.
- 119-sres-897: A resolution honoring the life, service, and legacy of the Honorable Jon Llewellyn Kyl, former Senator for the State of Arizona.
- 119-sres-801: A resolution honoring the life and legacy of the Honorable Lindsey Olin Graham, a Senator from the State of South Carolina.
- 119-sres-755: A resolution honoring the life of the Honorable Donald W. Riegle, Jr., former Senator for the State of Michigan.

## Sources
- [119-s-1414 on Congress.gov](https://www.congress.gov/bill/119th-congress/senate-bill/1414)

## Related
- [119-s-1954: Biosimilar Red Tape Elimination Act](https://policyrisk.com/legislation/119-s-1954)
- [119-s-1302: Increasing Transparency in Generic Drug Applications Act](https://policyrisk.com/legislation/119-s-1302)
- [119-sres-913: A resolution relating to the death of the Honorable Nancy Kassebaum, former Uni…](https://policyrisk.com/legislation/119-sres-913)
- [119-sres-897: A resolution honoring the life, service, and legacy of the Honorable Jon Llewel…](https://policyrisk.com/legislation/119-sres-897)
- [119-sres-801: A resolution honoring the life and legacy of the Honorable Lindsey Olin Graham,…](https://policyrisk.com/legislation/119-sres-801)
- [119-sres-755: A resolution honoring the life of the Honorable Donald W. Riegle, Jr., former S…](https://policyrisk.com/legislation/119-sres-755)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-s-1414 (as of 2026-09-16).