This bill seeks to enhance the Food and Drug Administration's inspection processes for establishments involved in the manufacture of biosimilar biological products . It mandates that the Secretary conduct a public meeting within 180 days of enactment to discuss the use of mutual recognition agreements for inspections. Following this meeting, a report with recommendations on expanding and improving these agreements, including their application to remote regulatory assessments and virtual interactions, must be issued to Congress and made publicly available. Furthermore, the legislation directs the Secretary to update inspection processes and tools to advance a risk-based approach , increasing the utilization of remote regulatory assessments and other alternative tools to improve inspection efficiency. Within one year, the Secretary must also develop and publish a strategic plan to address challenges in inspecting domestic biosimilar biological product establishments. This plan will cover issues such as recruiting and retaining inspection staff, improving internal and external communication, and resolving inspection-related questions earlier in the review process for biosimilar applications.
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Timeline
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Health
Biosimilar Inspection Modernization Act of 2025
USA119th CongressS-3510| Senate
| Updated: 12/16/2025
This bill seeks to enhance the Food and Drug Administration's inspection processes for establishments involved in the manufacture of biosimilar biological products . It mandates that the Secretary conduct a public meeting within 180 days of enactment to discuss the use of mutual recognition agreements for inspections. Following this meeting, a report with recommendations on expanding and improving these agreements, including their application to remote regulatory assessments and virtual interactions, must be issued to Congress and made publicly available. Furthermore, the legislation directs the Secretary to update inspection processes and tools to advance a risk-based approach , increasing the utilization of remote regulatory assessments and other alternative tools to improve inspection efficiency. Within one year, the Secretary must also develop and publish a strategic plan to address challenges in inspecting domestic biosimilar biological product establishments. This plan will cover issues such as recruiting and retaining inspection staff, improving internal and external communication, and resolving inspection-related questions earlier in the review process for biosimilar applications.