Bill · S. 3510· Senate(119-S-3510)
Biosimilar Inspection Modernization Act of 2025
- Introduced
- 12/16/2025
- Last activity
- 12/16/2025 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Sponsored by
- Ted Budd
- Cosponsors
- - 0 - 1
- Introduced
- In Committee
What this bill would do
This bill is known as the Biosimilar Inspection Modernization Act of 2025. It aims to improve how the Food and Drug Administration inspects places that make biosimilar biological products. The bill requires the Secretary of Health and Human Services to hold a public meeting and issue a report on mutual recognition agreements. It also directs the Secretary to update inspection processes and tools to use a risk-based approach. Finally, the bill requires the creation of a strategic plan to address domestic inspection challenges within one year of enactment.
Yes· 3 of 10
Does this lower the price of prescription medicines?+4
Streamlining the regulatory inspection process for biosimilars can help foster competition and potentially lower prescription drug costs for consumers.
Would business owners be better off under this?+3
Biosimilar application sponsors and pharmaceutical establishments benefit from clearer inspection frameworks, remote assessment tools, and better communication.
Does this make health care easier to get in general?+3
Modernizing biosimilar inspections helps ensure timely review and availability of important biological products for patients.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
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Section 3 requires the Secretary to hold a public meeting and issue a report on mutual recognition agreements. This could benefit the public by discussing improvements and expanding the use of these agreements for inspections.
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Section 4 directs the Secretary to update inspection processes to advance a risk-based approach. This could help increase the use of remote regulatory assessments and maximize alternative tools to improve inspection efficiency.
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Section 5 requires the Secretary to develop and publish a strategic plan to address domestic inspection challenges. This could benefit people by focusing on recruiting and retaining inspection staff and improving internal and external communications with application sponsors.
Potential Negative Impacts for People
- The provided text does not contain any specific sections or provisions that outline potential negative consequences or burdens for individuals or groups of people in the United States.
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 Business Owners+3Good For Low Income Households+2Good For Middle Class Households+2Good For Retirees+2Good For Seniors+2
- Healthcare
- Reduces Prescription Drug Costs+4Improves Healthcare Access+3
- Economy And Finance
- Improves Consumer Protection+3
- Governance And Ideology
- Improves Government Transparency+3
- National Security And Foreign Policy
- Improves International Alliances+2
- 12/16/2025
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 1 Cosponsor added.
- Introduced in Senate
Maggie HassanDemocrat · New Hampshire