Biosimilar Inspection Modernization Act of 2025

This bill aims to improve how the Food and Drug Administration (FDA) inspects facilities that make biosimilar biological products. It requires a public meeting and report on using mutual recognition agreements with foreign regulators for these inspections, directs the FDA to update its inspection tools to allow more remote assessments and alternative methods, and mandates a strategic plan to address challenges in inspecting domestic biosimilar facilities.

Sec. 2, Definitions: Defines key terms used in the bill. A 'biosimilar biological product' is a biological product licensed under a specific section of the Public Health Service Act. A 'biosimilar biological product establishment' is a facility that makes such a product and is registered with the FDA. The 'Secretary' refers to the Secretary of Health and Human Services, acting through the FDA Commissioner.

Sec. 3, Public meeting and report on mutual recognition agreements: Requires the Secretary to hold a public meeting within 180 days of the bill's enactment to discuss how mutual recognition agreements are used for inspecting biosimilar facilities and how they could be expanded. Within 180 days after that meeting, the Secretary must issue a public report to Congress with recommendations on using these agreements for such inspections.

Sec. 4, Ensuring flexibility in inspection tools: Directs the Secretary to update inspection processes and tools to use a risk-based approach for evaluating biosimilar facilities. This includes increasing the use of remote regulatory assessments and maximizing the use of alternative tools, as described in a specific FDA guidance document, to improve inspection efficiency.

Sec. 5, FDA strategic plan on domestic inspection improvements for biosimilar biological facilities: Requires the Secretary to develop and publish a strategic plan within one year of the bill's enactment. The plan must address ways the FDA will handle challenges in inspecting domestic biosimilar facilities, including recruiting and retaining staff, specific inspection challenges, improving internal communication, and expanding communication with product sponsors about inspection requirements.