Bills · S 1954
REPORTED· 119TH CONGRESS
Senate BillS 1954Licensing and registrationsDrug safety, medical device, and laboratory regulation
Biosimilar Red Tape Elimination Act
INTRO JUN 4· LAST ACTION JUL 27
READING
12MIN
COSPONSORS
5BIPARTISAN
READER REACTIONS0 TOTAL
NO VOTES YET · BE THE FIRST
- Introduced only
LEGISLATIVE PROGRESS
STEP 3 / 8Introduced
In Committee
Reported
Passed Senate
Passed House
Conference
To President
Became Law
WHAT THE BILL DOES
AI-writtenBiological medicines are often among the most expensive drugs, and biosimilars are crucial for introducing competition and driving down costs. However, the current system requires a separate, time-consuming, and costly review process for biosimilars to achieve 'interchangeable' status, which is key to their uptake and ability to compete effectively with brand-name drugs. This often delays patient access to these more affordable options.
If this bill becomes law, it would remove a significant regulatory hurdle, potentially accelerating the availability of interchangeable biosimilars. This could lead to more competitive pricing, making vital biological treatments more accessible and affordable for a broader range of patients. If the bill does not pass, the current system of separate biosimilar and interchangeability approvals would remain, potentially continuing to delay access to lower-cost alternatives and limiting competition in the biological drug market.
KEY PROVISIONS
4AI-extractedPROVISION 01
Removes the separate approval pathway for 'interchangeability' for biosimilar biological products.
This means that once a biosimilar is approved, it automatically gains the status that allows pharmacists to substitute it for the reference product without a new prescription.
PROVISION 02
States that a biological product licensed as a biosimilar on or after a 60-day transition date will be deemed interchangeable with its reference product upon licensure.
This establishes the automatic interchangeability for newly approved biosimilars, streamlining their market entry.
PROVISION 03
Preserves existing 'first interchangeable' exclusivity periods for biosimilars licensed before the bill's enactment.
This ensures that companies that previously earned exclusivity for their interchangeable biosimilars retain those benefits.
PROVISION 04
Requires the FDA to update or revoke its guidance documents related to demonstrating interchangeability within 18 months.
This ensures that the FDA's published guidance aligns with the new legal framework for biosimilar interchangeability.
SPONSORSHIP
1 + 5
R· Utah
YRS IN OFFICE
15
BILLS LED
138
COSPONSOR BREAKDOWNBIPARTISAN · 80%
DEM 3 REP 2 IND 0
ACTION TIMELINE
9 EVENTSJUL 27
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
JUL 27
Placed on Senate Legislative Calendar under General Orders. Calendar No. 521.
JUN 17
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
JUN 17
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
BILL INFO
TypeSenate Bill
NumberS 1954
Congress119th
StatusReported
IntroducedJun 4, 2025
Last actionJul 27, 2026
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REPORTED· 119TH CONGRESS · HEALTH, EDUCATION, LABOR, AND PENSIONS COMMITTEE · INTRODUCED JUN 4, 2025
Senate BillS 1954Licensing and registrationsDrug safety, medical device, and laboratory regulation
Biosimilar Red Tape Elimination Act
INTRODUCED JUN 4, 2025· LAST ACTION JUL 27, 2026
PASSAGE CHANCES
—%
READING
12 min
COSPONSORS
5
COMPLEXITY
Moderate
