Biosimilar Inspection Modernization Act of 2025

This bill modernizes how the FDA inspects facilities manufacturing biosimilar drugs (similar but not identical versions of biologic medicines) in the U.S. It requires the FDA to hold a public meeting and issue a report on expanding international inspection agreements, update inspection tools to increase remote assessments (like virtual site reviews), and develop a strategic plan within a year to address staffing and communication challenges specific to biosimilar facility inspections. The bill directly affects FDA inspectors, biosimilar drug manufacturers, and the FDA's inspection processes for domestic facilities. It focuses on improving inspection efficiency and communication without changing drug approval standards or safety requirements.