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Biologics Competition Act of 2022

USA117th CongressHR-8877| House 
| Updated: 9/20/2022
Mariannette Miller-Meeks

Mariannette Miller-Meeks

Republican Representative

Iowa

Cosponsors (4)
Gregory F. Murphy (Republican)Stephanie I. Bice (Republican)Ann M. Kuster (Democratic)Nanette Diaz Barragán (Democratic)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Biologics Competition Act of 2022 This bill requires the Food and Drug Administration (FDA) to evaluate (1) the differences between the requirements that apply to interchangeable biologics and the requirements that apply to therapeutically equivalent ratings for generic drugs, and (2) the effects of these differences on the approval of interchangeable biologics. The FDA must update the Purple Book with changes that better align the ways these requirements are communicated while still maintaining each distinct approval pathway. The Purple Book is an FDA publication that lists approved biological products, including biosimilars and interchangeable biologics. Interchangeable biologics are biologics that may be substituted for the original product without consulting the prescriber, similar to how generic drugs may be substituted for brand-name drugs based on therapeutic equivalence.
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Timeline
Sep 19, 2022
Introduced in House
Sep 19, 2022
Referred to the House Committee on Energy and Commerce.
Sep 20, 2022
Referred to the Subcommittee on Health.
  • September 19, 2022
    Introduced in House


  • September 19, 2022
    Referred to the House Committee on Energy and Commerce.


  • September 20, 2022
    Referred to the Subcommittee on Health.

Health

Biologics Competition Act of 2022

USA117th CongressHR-8877| House 
| Updated: 9/20/2022
Biologics Competition Act of 2022 This bill requires the Food and Drug Administration (FDA) to evaluate (1) the differences between the requirements that apply to interchangeable biologics and the requirements that apply to therapeutically equivalent ratings for generic drugs, and (2) the effects of these differences on the approval of interchangeable biologics. The FDA must update the Purple Book with changes that better align the ways these requirements are communicated while still maintaining each distinct approval pathway. The Purple Book is an FDA publication that lists approved biological products, including biosimilars and interchangeable biologics. Interchangeable biologics are biologics that may be substituted for the original product without consulting the prescriber, similar to how generic drugs may be substituted for brand-name drugs based on therapeutic equivalence.
View Full Text

Suggested Questions

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

Timeline
Sep 19, 2022
Introduced in House
Sep 19, 2022
Referred to the House Committee on Energy and Commerce.
Sep 20, 2022
Referred to the Subcommittee on Health.
  • September 19, 2022
    Introduced in House


  • September 19, 2022
    Referred to the House Committee on Energy and Commerce.


  • September 20, 2022
    Referred to the Subcommittee on Health.
Mariannette Miller-Meeks

Mariannette Miller-Meeks

Republican Representative

Iowa

Cosponsors (4)
Gregory F. Murphy (Republican)Stephanie I. Bice (Republican)Ann M. Kuster (Democratic)Nanette Diaz Barragán (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

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