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Study to streamline access to cheaper interchangeable biosimilar drugs

This law requires the Department of Health to conduct a detailed study on the process of designating biosimilar biological products as interchangeable. The goal is to understand the challenges and data required for this status. Streamlining access to interchangeable biosimilars could increase market competition, potentially resulting in lower treatment costs for citizens.
Key points
Mandates the FDA to conduct a study on how biosimilar drugs achieve "interchangeable" status.
The report must assess the data needed for approval and the challenges faced by manufacturers.
Increased approval of interchangeable biosimilars could lead to lower prices for expensive biological medicines.
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Expired
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Additional Information
Print number: 118_S_1522
Sponsor: Sen. Marshall, Roger [R-KS]
Process start date: 2023-05-10
Lustra uses Artificial Intelligence. Verify details in source documents.
Summarized by: gemini-2.5-flash-preview-09-2025
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

A bill to require the Secretary of Health and Human Services to conduct a study on the designation of biosimilar biological products as interchangeable.

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 118_S_1522.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2023-05-10.

What are the main provisions?

Key points include:

  • Mandates the FDA to conduct a study on how biosimilar drugs achieve "interchangeable" status.
  • The report must assess the data needed for approval and the challenges faced by manufacturers.
  • Increased approval of interchangeable biosimilars could lead to lower prices for expensive biological medicines.
What is the specific legal status?

The current status is Expired.

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. Marshall, Roger [R-KS].

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 2025-12-26.

CATEGORIES

Health