# 119-hr-5526: Biosimilar Red Tape Elimination Act

119-hr-5526, Biosimilar Red Tape Elimination Act, is a 119th Congress bill sponsored by Rep. Pfluger, August [R-TX-11] (R-TX); status introduced; PRIA reads it as touching household money (as of 2026-07-23).

- Canonical: https://policyrisk.com/legislation/119-hr-5526
- As of: 2026-07-23
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-5526
- Congress: 119
- Title: Biosimilar Red Tape Elimination Act
- Status: introduced
- Introduced: 2025-09-19
- Sponsor: Rep. Pfluger, August [R-TX-11] (R-TX)
- Cosponsors: 10
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-07-23

## Summary

**Deems many biosimilars interchangeable with their reference biologics under a new 60-day transition framework while preserving first-interchangeable exclusivity.** It would reorganize the 351(k) approval rules and require the FDA to issue updated guidance within 18 months. - Patients and prescribers: A biosimilar licensed on or after the transition date would generally be treated as interchangeable at licensure, or become interchangeable on the transition date if licensed earlier. The transition date is 60 days after enactment. - Biologic manufacturers: The bill preserves any unexpired "first interchangeable" exclusivity for its remaining term and delays deemed interchangeability for other products that rely on the same reference product until that exclusivity ends. - FDA and regulators: It tightens and renumbers the statutory 351(k) framework, simplifies interchangeability criteria, makes conforming edits to related law, and requires updated or new guidance on interchangeability and biosimilarity within 18 months of enactment.

## Cosponsors (10)

- Rep. Landsman, Greg [D-OH-1] (D-OH), 2025-09-19T00:00:00.000Z
- Rep. Auchincloss, Jake [D-MA-4] (D-MA), 2025-10-17T00:00:00.000Z
- Rep. Crenshaw, Dan [R-TX-2] (R-TX), 2025-11-10T00:00:00.000Z
- Rep. Vasquez, Gabe [D-NM-2] (D-NM), 2025-12-09T00:00:00.000Z
- Rep. Owens, Burgess [R-UT-4] (R-UT), 2026-02-04T00:00:00.000Z
- Rep. Fine, Randy [R-FL-6] (R-FL), 2026-03-09T00:00:00.000Z
- Rep. Moore, Blake D. [R-UT-1] (R-UT), 2026-05-21T00:00:00.000Z
- Rep. Sorensen, Eric [D-IL-17] (D-IL), 2026-06-04T00:00:00.000Z
- Rep. Goldman, Craig A. [R-TX-12] (R-TX), 2026-07-15T00:00:00.000Z
- Rep. Wittman, Robert J. [R-VA-1] (R-VA), 2026-07-21T00:00:00.000Z

## Provisions PRIA read

- Faster biosimilar substitutions for patients: benefit, medium. If enacted, most FDA-licensed biosimilars would be treated as interchangeable with their brand-name reference drug. Biosimilars licensed before the transition date would become interchangeable on that date, which is 60 days after enactment. Biosimilars licensed on or after that date would be interc…
- Clearer FDA rules for biosimilars: benefit, low. If enacted, FDA would update and issue biosimilar guidance within 18 months. The agency would revise its 2019 and 2024 interchangeability guidances and spell out what data applicants must submit. Revised drafts or final versions would be due within 18 months after each comment period closes. The bi…

## Related bills

- 119-hr-1262: Mikaela Naylon Give Kids a Chance Act
- 119-hr-842: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act
- 119-hr-1422: Enhanced Iran Sanctions Act of 2025
- 119-hr-3514: Improving Seniors’ Timely Access to Care Act of 2025
- 119-hr-9250: Great American Outdoors Act 250
- 119-hr-5401: Pay Our Troops Act of 2026

## Sources
- [119-hr-5526 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/5526)

## Related
- [119-hr-1262: Mikaela Naylon Give Kids a Chance Act](https://policyrisk.com/legislation/119-hr-1262)
- [119-hr-842: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage A…](https://policyrisk.com/legislation/119-hr-842)
- [119-hr-1422: Enhanced Iran Sanctions Act of 2025](https://policyrisk.com/legislation/119-hr-1422)
- [119-hr-3514: Improving Seniors’ Timely Access to Care Act of 2025](https://policyrisk.com/legislation/119-hr-3514)
- [119-hr-9250: Great American Outdoors Act 250](https://policyrisk.com/legislation/119-hr-9250)
- [119-hr-5401: Pay Our Troops Act of 2026](https://policyrisk.com/legislation/119-hr-5401)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-5526 (as of 2026-07-23).