Bill > S3510

This bill, the Biosimilar Inspection Modernization Act of 2025, aims to improve how the Food and Drug Administration (FDA) inspects facilities that manufacture biosimilar biological products, which are similar versions of approved biologic drugs. The bill mandates that the Secretary of Health and Human Services, acting through the FDA Commissioner, hold a public meeting and then issue a report with recommendations on using mutual recognition agreements (MRAs) for inspections. MRAs allow countries to recognize each other's inspections, potentially streamlining the process. The bill also directs the FDA to update its inspection processes to be more risk-based and to increase the use of remote regulatory assessments and other alternative tools, as outlined in existing FDA guidance, to make inspections more efficient. Finally, the FDA is required to develop and publish a strategic plan within one year of the bill's enactment to address challenges related to inspecting domestic biosimilar facilities, including staffing, specific inspection issues, internal communication, and improving communication with companies seeking approval for biosimilar products.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/3510/all-info