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Better Biosimilar Drug Inspections: Enhanced Safety and Accessibility

This act aims to improve how the Food and Drug Administration (FDA) inspects facilities manufacturing biosimilar drugs, which are similar to original biological medicines. By modernizing inspection methods and increasing their efficiency, citizens can expect biosimilar drugs on the market to be safer and more reliable. The goal is to ensure high quality of these products, directly impacting health and treatment accessibility.
Key points
New Inspection Methods: The FDA will increase the use of remote regulatory assessments and other modern tools to check biosimilar drug manufacturers, aiming for greater efficiency and accuracy.
International Cooperation: The act promotes discussion and reporting on using mutual recognition agreements to streamline inspections, including with trusted foreign partners.
FDA Strategic Plan: The agency will develop a plan to improve domestic inspections, including staff recruitment and communication, to ensure consistent high quality of biosimilar drugs.
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Introduced
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Additional Information
Print number: 119_S_3510
Sponsor: Sen. Budd, Ted [R-NC]
Process start date: 2025-12-16
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OFFICIAL LEGAL TITLE

Biosimilar Inspection Modernization Act of 2025

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 119_S_3510.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2025-12-16.

What are the main provisions?

Key points include:

  • New Inspection Methods: The FDA will increase the use of remote regulatory assessments and other modern tools to check biosimilar drug manufacturers, aiming for greater efficiency and accuracy.
  • International Cooperation: The act promotes discussion and reporting on using mutual recognition agreements to streamline inspections, including with trusted foreign partners.
  • FDA Strategic Plan: The agency will develop a plan to improve domestic inspections, including staff recruitment and communication, to ensure consistent high quality of biosimilar drugs.
What is the specific legal status?

The current status is Introduced.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Sen. Budd, Ted [R-NC].

What is the latest detailed status?

The latest detailed status is: Introduced in Senate

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2026-01-11.

CATEGORIES

Health