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Biosimilar Red Tape Elimination Act

USA119th CongressS-1954| Senate 
| Updated: 6/4/2025
Mike Lee

Mike Lee

Republican Senator

Utah

Cosponsors (4)
Margaret Wood Hassan (Democratic)Ben Ray Luján (Democratic)Eric Schmitt (Republican)Rand Paul (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
The Biosimilar Red Tape Elimination Act aims to significantly simplify the process for biological products to be considered interchangeable with their reference products. It amends the Public Health Service Act to establish that a biological product licensed as biosimilar will generally be deemed to be interchangeable with its reference product, removing the requirement for a separate determination. This change is intended to streamline market entry for biosimilars. The bill specifies the timing for this deemed interchangeability, differentiating between products licensed before and after a transition date , which is 60 days after the Act's enactment. For most products, interchangeability will occur upon licensure or the transition date. However, it includes provisions to preserve any existing first interchangeable exclusivity periods for other biological products that relied on the same reference product, delaying deemed interchangeability until such exclusivity expires. Furthermore, the legislation includes several conforming amendments across related statutes to align with the new framework, removing outdated references to separate interchangeability standards. It also mandates that the Secretary of Health and Human Services update existing guidance and issue new guidance within 18 months to reflect these changes, specifically requiring the revision or revocation of previous guidance documents on demonstrating interchangeability.
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Timeline

Bill from Previous Congress

S 117-6
Biosimilar Red Tape Elimination Act

Bill from Previous Congress

S 118-2305
Biosimilar Red Tape Elimination Act
Jun 4, 2025
Introduced in Senate
Jun 4, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sep 19, 2025

Latest Companion Bill Action

HR 119-5526
Introduced in House
  • Bill from Previous Congress

    S 117-6
    Biosimilar Red Tape Elimination Act


  • Bill from Previous Congress

    S 118-2305
    Biosimilar Red Tape Elimination Act


  • June 4, 2025
    Introduced in Senate


  • June 4, 2025
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • September 19, 2025

    Latest Companion Bill Action

    HR 119-5526
    Introduced in House

Health

Related Bills

  • HR 119-5526: Biosimilar Red Tape Elimination Act

Biosimilar Red Tape Elimination Act

USA119th CongressS-1954| Senate 
| Updated: 6/4/2025
The Biosimilar Red Tape Elimination Act aims to significantly simplify the process for biological products to be considered interchangeable with their reference products. It amends the Public Health Service Act to establish that a biological product licensed as biosimilar will generally be deemed to be interchangeable with its reference product, removing the requirement for a separate determination. This change is intended to streamline market entry for biosimilars. The bill specifies the timing for this deemed interchangeability, differentiating between products licensed before and after a transition date , which is 60 days after the Act's enactment. For most products, interchangeability will occur upon licensure or the transition date. However, it includes provisions to preserve any existing first interchangeable exclusivity periods for other biological products that relied on the same reference product, delaying deemed interchangeability until such exclusivity expires. Furthermore, the legislation includes several conforming amendments across related statutes to align with the new framework, removing outdated references to separate interchangeability standards. It also mandates that the Secretary of Health and Human Services update existing guidance and issue new guidance within 18 months to reflect these changes, specifically requiring the revision or revocation of previous guidance documents on demonstrating interchangeability.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

S 117-6
Biosimilar Red Tape Elimination Act

Bill from Previous Congress

S 118-2305
Biosimilar Red Tape Elimination Act
Jun 4, 2025
Introduced in Senate
Jun 4, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sep 19, 2025

Latest Companion Bill Action

HR 119-5526
Introduced in House
  • Bill from Previous Congress

    S 117-6
    Biosimilar Red Tape Elimination Act


  • Bill from Previous Congress

    S 118-2305
    Biosimilar Red Tape Elimination Act


  • June 4, 2025
    Introduced in Senate


  • June 4, 2025
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • September 19, 2025

    Latest Companion Bill Action

    HR 119-5526
    Introduced in House
Mike Lee

Mike Lee

Republican Senator

Utah

Cosponsors (4)
Margaret Wood Hassan (Democratic)Ben Ray Luján (Democratic)Eric Schmitt (Republican)Rand Paul (Republican)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 119-5526: Biosimilar Red Tape Elimination Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted