Biosimilar Inspection Modernization Act of 2025

This bill directs the Food and Drug Administration (FDA) to change how it inspects facilities that make biosimilar biological products, which are drugs licensed as highly similar to existing biological medicines. Within 180 days, the FDA must hold a public meeting on using mutual recognition agreements, which let it rely on inspections by foreign regulators, and then send Congress a public report with recommendations. The FDA must update its inspection processes to use a risk-based approach and increase its use of remote assessments and other alternative tools. Within one year, the FDA must publish a strategic plan on challenges in inspecting U.S. biosimilar facilities, including staffing and communication with drug makers.

Full text and official record on Congress.gov

Sponsors

• Ted Budd Republican sponsor
• 1 cosponsors