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Expedited Biosimilar Access: Streamlined Clinical Study Requirements

This act aims to accelerate the market entry of biosimilar drugs, which are more affordable alternatives to expensive biological medicines. By simplifying clinical study requirements, citizens may gain faster access to necessary therapies, potentially lowering treatment costs and increasing drug availability.
Key points
Simplified Clinical Studies: Biosimilar drugs will not always require tests for immune responses, drug action in the body, or comparative efficacy.
Faster Drug Approval: The changes could reduce the time needed for biosimilar drugs to be approved for sale.
Potential Lower Treatment Costs: Greater availability of cheaper alternatives may lead to lower drug expenditures for patients and healthcare systems.
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Introduced
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Additional Information
Print number: 119_S_1414
Sponsor: Sen. Paul, Rand [R-KY]
Process start date: 2025-04-10
Lustra uses Artificial Intelligence. Verify details in source documents.
Summarized by: gemini-2.5-flash
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

Expedited Access to Biosimilars Act

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 119_S_1414.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2025-04-10.

What are the main provisions?

Key points include:

  • Simplified Clinical Studies: Biosimilar drugs will not always require tests for immune responses, drug action in the body, or comparative efficacy.
  • Faster Drug Approval: The changes could reduce the time needed for biosimilar drugs to be approved for sale.
  • Potential Lower Treatment Costs: Greater availability of cheaper alternatives may lead to lower drug expenditures for patients and healthcare systems.
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. Paul, Rand [R-KY].

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 2025-12-23.

CATEGORIES

Health