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119-s-3510119th CongressWALLET

Biosimilar Inspection Modernization Act of 2025

Sponsored By: Senator Budd, Ted [R-NC]

Introduced

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.

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  • 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.

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Bill Overview

Analyzed Economic Effects

1 provisions identified: 0 benefits, 0 costs, 1 mixed.

Modernize biosimilar facility inspections

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 coordination, and more communication with sponsors of 351(k) applications. The Secretary would update inspection tools to use a risk-based approach and increase remote regulatory assessments consistent with FDA guidance dated June 24, 2025. The Secretary would hold a public meeting on mutual recognition agreements within 180 days and deliver a recommendations report to congressional health committees within 180 days after that meeting. This mainly affects biosimilar drug makers and FDA inspection staff.

Sponsors & CoSponsors

Sponsor

Budd, Ted [R-NC]

NC • R

Cosponsors

  • Sen. Hassan, Margaret Wood [D-NH]

    NH • D

    Sponsored 12/16/2025

Roll Call Votes

No roll call votes available for this bill.

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