The Biosimilar Inspection Modernization Act aims to improve how the Food and Drug Administration inspects factories that manufacture biosimilar drugs—cheaper versions of expensive biologic medications. The bill requires the FDA to hold a public meeting and issue a report on using mutual recognition agreements with foreign regulators to conduct inspections more efficiently, potentially including remote assessments and virtual expert consultations. The legislation also directs the FDA to modernize its inspection tools to use risk-based approaches and expand remote regulatory assessments for biosimilar manufacturers. Within one year, the FDA must develop a strategic plan addressing challenges in inspecting domestic biosimilar facilities, including staffing issues, communication gaps, and better coordination with drug manufacturers early in the approval process. The bill does not specify new funding but establishes clear timelines—180 days for the public meeting and report, and one year for the strategic plan.
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