Legis Daily

Biosimilar Red Tape Elimination Act

USA118th CongressS-2305| Senate 
| Updated: 7/13/2023
Mike Lee

Mike Lee

Republican Senator

Utah

Cosponsors (4)
Mike Braun (Republican)Ben Ray Luján (Democratic)J. D. Vance (Republican)Rand Paul (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Biosimilar Red Tape Elimination Act This bill removes certain requirements for biosimilars to be designated as interchangeable. (Biosimilars that are designated as interchangeable may be substituted for the reference product at a pharmacy without a new prescription, depending on state pharmacy laws.) Specifically, the bill establishes a presumption that an approved biosimilar is interchangeable with the reference product without the need for additional evidence from the manufacturer, and it removes the applicable exclusivity periods for a first interchangeable biosimilar (i.e., a product that is the first interchangeable biosimilar to be approved with respect to the reference product). The Food and Drug Administration (FDA) may require a manufacturer of a biosimilar to conduct a safety study with respect to switching or alternating between the biosimilar and the reference product, but only after the FDA briefs certain members of specified congressional committees to explain why the study is necessary.
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Timeline

Bill from Previous Congress

S 117-6
Biosimilar Red Tape Elimination Act
Jul 13, 2023
Introduced in Senate
Jul 13, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    S 117-6
    Biosimilar Red Tape Elimination Act


  • July 13, 2023
    Introduced in Senate


  • July 13, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Biosimilar Red Tape Elimination Act

USA118th CongressS-2305| Senate 
| Updated: 7/13/2023
Biosimilar Red Tape Elimination Act This bill removes certain requirements for biosimilars to be designated as interchangeable. (Biosimilars that are designated as interchangeable may be substituted for the reference product at a pharmacy without a new prescription, depending on state pharmacy laws.) Specifically, the bill establishes a presumption that an approved biosimilar is interchangeable with the reference product without the need for additional evidence from the manufacturer, and it removes the applicable exclusivity periods for a first interchangeable biosimilar (i.e., a product that is the first interchangeable biosimilar to be approved with respect to the reference product). The Food and Drug Administration (FDA) may require a manufacturer of a biosimilar to conduct a safety study with respect to switching or alternating between the biosimilar and the reference product, but only after the FDA briefs certain members of specified congressional committees to explain why the study is necessary.
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
Jul 13, 2023
Introduced in Senate
Jul 13, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    S 117-6
    Biosimilar Red Tape Elimination Act


  • July 13, 2023
    Introduced in Senate


  • July 13, 2023
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mike Lee

Mike Lee

Republican Senator

Utah

Cosponsors (4)
Mike Braun (Republican)Ben Ray Luján (Democratic)J. D. Vance (Republican)Rand Paul (Republican)

Health, Education, Labor, and Pensions Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted