S 1954 United States Senate · 119th Congress

Biosimilar Red Tape Elimination Act

This bill simplifies the approval process for biosimilar drugs - medicines that are highly similar to, but not identical to, existing biologic drugs. It amends the Public Health Service Act to clarify when biosimilars are deemed "interchangeable" with the original drug (allowing pharmacists to substitute them without a doctor's specific order), adjusts exclusivity periods for existing biosimilars, and sets a 60-day transition period after enactment. The bill also requires the FDA to update its guidance documents within 18 months to reflect these changes. This directly affects pharmaceutical companies developing biosimilars, the FDA in its review process, and ultimately patients seeking more affordable treatment options.
Bill status in committee 1 of 4 stages cleared
Introduction
Jun 2025
Committee Review
Floor Vote
President
Introduced Jun 4, 2025 Last action Jul 27, 2026
Floor votes

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Full legislative history

Actions timeline

Total actions
5
Key actions
2
Committee
3
Jul 27, 2026
Upper · Passed
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
upper
Jun 17, 2026
Upper · Passed
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
upper
Jun 4, 2025
Committee
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
upper
Jun 4, 2025
Introduced
Introduced in Senate
upper
1 primary · 5 co-sponsors

Sponsors