# 119-s-1954: Biosimilar Red Tape Elimination Act

119-s-1954, Biosimilar Red Tape Elimination Act, is a 119th Congress bill sponsored by Sen. Lee, Mike [R-UT] (R-UT); status in_committee; PRIA reads it as touching household money (as of 2026-08-05).

- Canonical: https://policyrisk.com/legislation/119-s-1954
- As of: 2026-08-05
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-s-1954
- Congress: 119
- Title: Biosimilar Red Tape Elimination Act
- Status: in_committee
- Introduced: 2025-06-04
- Sponsor: Sen. Lee, Mike [R-UT] (R-UT)
- Cosponsors: 5
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-08-05

## Summary

**Clarifies when biosimilars are treated as interchangeable with their reference biologics.** This bill would rewrite the biosimilar rules in section 351(k) to create a clear transition framework, preserve existing exclusivity, and force updated agency guidance to reflect the new rules. - Manufacturers and applicants would see a restructured 351(k) pathway with consolidated application requirements and pared references to interchangeable labeling. This aims to standardize what information sponsors must submit. - Timing and market effects hinge on a defined transition date set at 60 days after enactment. Products licensed on or after that date would generally be deemed interchangeable at licensure. Products licensed before that date would become deemed interchangeable on the transition date. In both cases interchangeability is postponed if another product relying on the same reference biologic holds an active first‑interchangeable exclusivity. - The Food and Drug Administration would have deadlines to update guidance. The agency must revise interchangeability guidance and biosimilarity data guidance within 18 months and after public comment. The bill also narrows when a biosimilar can be treated as a new active ingredient by tying that finding to pediatric indication rules and to whether the product could be licensed under 351(k).

## Cosponsors (5)

- Sen. Luján, Ben Ray [D-NM] (D-NM), 2025-06-04T00:00:00.000Z
- Sen. Paul, Rand [R-KY] (R-KY), 2025-06-04T00:00:00.000Z
- Sen. Hassan, Margaret Wood [D-NH] (D-NH), 2025-06-04T00:00:00.000Z
- Sen. Schmitt, Eric [R-MO] (R-MO), 2025-06-24T00:00:00.000Z
- Sen. Ossoff, Jon [D-GA] (D-GA), 2026-06-16T00:00:00.000Z

## Provisions PRIA read

- More biosimilars treated as interchangeable: benefit, medium. This bill would treat many biosimilar drugs as interchangeable with their reference drug. The transition date is 60 days after enactment. Biosimilars licensed on or after that date would be interchangeable when licensed, unless they rely on the same reference drug as an earlier biosimilar that had…
- Simpler rules for biosimilar approvals: benefit, low. This bill would rewrite several legal phrases and cross-references for biosimilars to reduce ambiguity. It would also limit when a 351(k) biosimilar counts as having a new active ingredient for pediatric study rules. Under the new test, a biosimilar would be treated as a new active ingredient only…

## Related bills

- 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.
- 119-sres-739: A resolution honoring the life and legacy of John Seymour, the late Senator for the State of California.
- 119-sres-723: A resolution honoring the life of Dirk Arthur Kempthorne, former United States Senator for the State of Idaho.

## Sources
- [119-s-1954 on Congress.gov](https://www.congress.gov/bill/119th-congress/senate-bill/1954)

## Related
- [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)
- [119-sres-739: A resolution honoring the life and legacy of John Seymour, the late Senator for…](https://policyrisk.com/legislation/119-sres-739)
- [119-sres-723: A resolution honoring the life of Dirk Arthur Kempthorne, former United States…](https://policyrisk.com/legislation/119-sres-723)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-s-1954 (as of 2026-08-05).