Bill · S. 1414· Senate(119-S-1414)
Expedited Access to Biosimilars Act
- Introduced
- 4/10/2025
- Last activity
- 7/27/2026 — Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.
- Sponsored by
- Rand Paul
- Cosponsors
- - 1 - 1
- Introduced
- On Calendar
What this bill would do
The "Expedited Access to Biosimilars Act" changes the rules for getting biological products licensed as biosimilars. It limits when the Secretary can require clinical studies that assess pharmacodynamics or efficacy. If these studies are required, the Secretary must provide a written determination and justification to the sponsor. The bill also streamlines biosimilar reviews and applies to applications submitted on or after the date it becomes law.
Yes· 3 of 32
Does this lower the price of prescription medicines?+8
Expediting biosimilar access increases market competition, which typically drives down the cost of biological drugs.
Would households on low incomes be better off under this?+6
Reducing the cost of high-priced biological products significantly benefits low-income patients.
Does this make health care easier to get in general?+6
Faster approval of biosimilars increases the availability of critical biological therapies for patients.
The opposite
Does this give people more protection from unfair business practices?-2
Reducing the requirement for certain clinical efficacy studies could potentially lower the data available for safety/efficacy verification.
Who it would affect, and how
Potential Positive Impacts for People
-
Faster Access to Biosimilars: By limiting the requirement for certain clinical studies on pharmacodynamics or efficacy (Section 2(a)(2)(II)(aa)), the process for licensing biosimilar products may be expedited.
-
Greater Transparency and Accountability: The Secretary must now provide a written determination or notice explaining why certain studies are necessary (Section 2(a)(2)(II)(bb)), which holds officials accountable for their requirements.
-
Predictability for Product Sponsors: The bill prevents the Secretary from amending a determination to require new studies unless there is a written agreement or a detailed scientific justification (Section 2(a)(2)(II)(cc)).
Potential Negative Impacts for People
- Reduced Clinical Data: The bill changes the requirements so that assessments of pharmacodynamics or efficacy are only required if the Secretary determines they are necessary (Section 2(a)(2)(II)(aa)), which could mean fewer clinical studies are conducted for some biosimilars.
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For Low Income Households+6Good For Middle Class Households+5Good For Business Owners+4Good For People With Disabilities+3Good For Retirees+3Good For High Income Households+2Good For Seniors+2Good For Veterans+2Good For African Americans+1Good For Asian Americans+1Good For Children+1Good For Hispanic Americans+1Good For Immigrants+1Good For L G B T Q Community+1Good For Men+1Good For Middle Aged+1Good For Native Americans+1Good For White Americans+1Good For Women+1Good For Young Adults+1
- Healthcare
- Reduces Prescription Drug Costs+8Improves Healthcare Access+6Reduces Hospital Costs+2Improves Veterans Healthcare+1Reduces Private Insurance Premiums+1
- Governance And Ideology
- Improves Government Transparency+4Improves Due Process+2
- Economy And Finance
- Improves Economic Growth+2Increases Job Creation+2Reduces Inflation+1Improves Consumer Protection-2
- National Security And Foreign Policy
- Improves Veterans Benefits+1
- Social Issues And Justice
- Improves Poverty Reduction+1
- 7/27/2026
- Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute. Without written report.
- Placed on Senate Legislative Calendar under General Orders. Calendar No. 520.
- 7/22/2026
- Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
- 7/20/2026
- 1 Cosponsor added.
- 6/3/2025
- 1 Cosponsor added.
- 4/10/2025
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Introduced in Senate
Maggie HassanDemocrat · New Hampshire
Mike LeeRepublican · Utah