Bills · S 1414
REPORTED· 119TH CONGRESS
Senate BillS 1414Licensing and registrationsDrug safety, medical device, and laboratory regulation
Expedited Access to Biosimilars Act
INTRO APR 10· LAST ACTION JUL 27
READING
5MIN
COSPONSORS
2BIPARTISAN
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-writtenVoters should care about this bill because it aims to tackle the high cost of prescription drugs, especially expensive biological medications. Biological drugs are often the most costly treatments available, and biosimilars are designed to be more affordable, equally effective alternatives. By potentially streamlining the approval process for biosimilars, this bill could lead to more competition in the market, driving down prices for these critical medicines.
If this bill becomes law, patients might gain quicker access to cheaper versions of vital drugs, potentially saving them money and increasing treatment accessibility. If it doesn't pass, the current, often lengthy and costly, approval process for biosimilars would remain, which could continue to limit the number of biosimilars available and keep drug prices higher. This bill directly relates to the ongoing public debate about healthcare costs and access to affordable medication.
KEY PROVISIONS
4AI-extractedPROVISION 01
Removes the automatic requirement for biosimilar drug applications to include studies on immunogenicity, pharmacodynamics, or comparative clinical efficacy.
This provision aims to reduce the time and cost associated with developing biosimilars, potentially speeding up their market entry.
PROVISION 02
Requires biosimilar applications to include clinical studies assessing pharmacokinetics sufficient to demonstrate safety, purity, and potency.
This ensures that a core set of studies demonstrating how the drug moves through the body and its overall safety and effectiveness are still mandatory.
PROVISION 03
Grants the FDA discretion to still require studies on immunogenicity, pharmacodynamics, or comparative clinical efficacy if deemed necessary.
This maintains the FDA's ability to ensure drug safety and effectiveness when specific concerns warrant additional testing.
PROVISION 04
Mandates that if the FDA requires additional studies, it must provide a written justification to the applicant by the earliest possible application filing date.
This ensures transparency and gives biosimilar manufacturers clear guidance early in the development process, preventing delays.
SPONSORSHIP
1 + 2
R· Kentucky
YRS IN OFFICE
15
BILLS LED
56
COSPONSOR BREAKDOWNBIPARTISAN · 100%
DEM 1 REP 1 IND 0
ACTION TIMELINE
7 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. 520.
JUL 22
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
APR 10
Introduced in Senate
BILL INFO
TypeSenate Bill
NumberS 1414
Congress119th
StatusReported
IntroducedApr 10, 2025
Last actionJul 27, 2026
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REPORTED· 119TH CONGRESS · HEALTH, EDUCATION, LABOR, AND PENSIONS COMMITTEE · INTRODUCED APR 10, 2025
Senate BillS 1414Licensing and registrationsDrug safety, medical device, and laboratory regulation
Expedited Access to Biosimilars Act
INTRODUCED APR 10, 2025· LAST ACTION JUL 27, 2026
PASSAGE CHANCES
—%
READING
5 min
COSPONSORS
2
COMPLEXITY
Moderate
