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Biosimilar Drugs: Automatic Interchangeability and Approval Procedure Changes

This bill aims to improve the requirements for making a determination of interchangeability of a biological product and its reference product. It establishes that a biological product licensed under the relevant subsection shall be deemed interchangeable with the reference product. Additionally, the bill removes provisions regarding exclusivity periods for the first interchangeable biological product and requires the Secretary to brief Congressional committees before mandating certain safety studies.
Key points
A biological product licensed under the relevant subsection is automatically deemed to be interchangeable with the reference product.
The bill removes provisions regarding market exclusivity periods for the first biological product determined to be interchangeable.
The Secretary may require studies on the risk of switching products only after briefing relevant Congressional committees on the necessity of such studies.
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Expired
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Additional Information
Print number: 118_S_2305
Sponsor: Sen. Lee, Mike [R-UT]
Process start date: 2023-07-13
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Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

Biosimilar Red Tape Elimination Act

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 118_S_2305.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2023-07-13.

What are the main provisions?

Key points include:

  • A biological product licensed under the relevant subsection is automatically deemed to be interchangeable with the reference product.
  • The bill removes provisions regarding market exclusivity periods for the first biological product determined to be interchangeable.
  • The Secretary may require studies on the risk of switching products only after briefing relevant Congressional committees on the necessity of such studies.
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. Lee, Mike [R-UT].

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 2025-12-30.

CATEGORIES

Health