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Automatic Interchangeability for Biosimilars: Red Tape Elimination Act.

This Act amends the Public Health Service Act to mandate that biological products licensed as biosimilars are deemed interchangeable with the reference product upon licensure. It eliminates the requirement for a separate determination of interchangeability by the Secretary. The bill establishes transition dates and preserves exclusivity periods for products licensed before the enactment of these new rules.
Key points
Biosimilar products are deemed interchangeable with the reference product immediately upon licensure (subject to transition rules).
The Act removes the requirement for a separate demonstration that a product meets interchangeability standards.
Existing first interchangeable exclusivity periods granted before the Act's enactment remain in effect until they expire.
The Secretary is required to update guidance documents regarding interchangeability and biosimilar review within 18 months.
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Introduced
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Additional Information
Print number: 119_HR_5526
Sponsor: Rep. Pfluger, August [R-TX-11]
Process start date: 2025-09-19
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Summarized by: gemini-3-pro-preview
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 119_HR_5526.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

When did the legislative process begin?

The process officially started on 2025-09-19.

What are the main provisions?

Key points include:

  • Biosimilar products are deemed interchangeable with the reference product immediately upon licensure (subject to transition rules).
  • The Act removes the requirement for a separate demonstration that a product meets interchangeability standards.
  • Existing first interchangeable exclusivity periods granted before the Act's enactment remain in effect until they expire.
  • The Secretary is required to update guidance documents regarding interchangeability and biosimilar review within 18 months.
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 Rep. Pfluger, August [R-TX-11].

What is the latest detailed status?

The latest detailed status is: Referred to the House Committee on Energy and Commerce.

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2026-01-19.

CATEGORIES

Health Economy