# 119-s-3510: Biosimilar Inspection Modernization Act of 2025

119-s-3510, Biosimilar Inspection Modernization Act of 2025, is a 119th Congress bill sponsored by Sen. Budd, Ted [R-NC] (R-NC); status introduced; PRIA reads it as touching household money (as of 2026-04-21).

- Canonical: https://policyrisk.com/legislation/119-s-3510
- As of: 2026-04-21
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-s-3510
- Congress: 119
- Title: Biosimilar Inspection Modernization Act of 2025
- Status: introduced
- Introduced: 2025-12-16
- Sponsor: Sen. Budd, Ted [R-NC] (R-NC)
- Cosponsors: 1
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-04-21

## Summary

**Modernize FDA inspections for biosimilar manufacturers.** This bill would push Health and Human Services to expand use of international agreements and remote assessments, update inspection tools for risk-based reviews, and publish a plan to strengthen domestic inspections. - Foreign and international manufacturers: Requires a public meeting within 180 days and a report within 180 days after that meeting on using mutual recognition agreements to inspect biosimilar product establishments and on expanding MRAs to include remote assessments and trusted foreign partners. - FDA inspectors and inspection process: Directs updates to inspection processes and tools so the agency can perform more risk-based reviews, increase use of remote regulatory assessments under FDA guidance, and maximize alternative tools to boost efficiency. - Sponsors of 351(k) applications and domestic facilities: Requires a strategic plan within 1 year to address recruiting and retaining inspection staff, challenges specific to domestic biosimilar facilities, improve internal FDA communication, and expand outreach to applicants about inspection needs and earlier resolution of inspection questions.

## Cosponsors (1)

- Sen. Hassan, Margaret Wood [D-NH] (D-NH), 2025-12-16T00:00:00.000Z

## Provisions PRIA read

- Modernize biosimilar facility inspections: mixed, low. This bill would require the HHS Secretary (through the FDA) to modernize inspections of facilities that make biosimilar drugs. Within 1 year, the Secretary would publish a strategic plan on hiring and keeping inspection staff, inspection challenges for biosimilar facilities, better internal FDA coo…

## Related bills

- 119-s-3923: Weather Research and Forecasting Innovation Reauthorization Act of 2026
- 119-s-3597: National Quantum Initiative Reauthorization Act of 2026
- 119-s-1782: Charlotte Woodward Organ Transplant Discrimination Prevention Act
- 119-s-1639: American Innovation and Jobs Act
- 119-s-1241: Sanctioning Russia Act of 2025
- 119-s-545: Combating Illicit Xylazine Act

## Sources
- [119-s-3510 on Congress.gov](https://www.congress.gov/bill/119th-congress/senate-bill/3510)

## Related
- [119-s-3923: Weather Research and Forecasting Innovation Reauthorization Act of 2026](https://policyrisk.com/legislation/119-s-3923)
- [119-s-3597: National Quantum Initiative Reauthorization Act of 2026](https://policyrisk.com/legislation/119-s-3597)
- [119-s-1782: Charlotte Woodward Organ Transplant Discrimination Prevention Act](https://policyrisk.com/legislation/119-s-1782)
- [119-s-1639: American Innovation and Jobs Act](https://policyrisk.com/legislation/119-s-1639)
- [119-s-1241: Sanctioning Russia Act of 2025](https://policyrisk.com/legislation/119-s-1241)
- [119-s-545: Combating Illicit Xylazine Act](https://policyrisk.com/legislation/119-s-545)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-s-3510 (as of 2026-04-21).