Legis Daily

Biologics Competition Act of 2023

USA118th CongressHR-1790| House 
| Updated: 3/31/2023
Mariannette Miller-Meeks

Mariannette Miller-Meeks

Republican Representative

Iowa

Cosponsors (4)
Gregory F. Murphy (Republican)Ann M. Kuster (Democratic)Dan Crenshaw (Republican)Nanette Diaz Barragán (Democratic)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Biologics Competition Act of 2023 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

Bill from Previous Congress

HR 117-8877
Biologics Competition Act of 2022
Mar 24, 2023
Introduced in House
Mar 24, 2023
Referred to the House Committee on Energy and Commerce.
Mar 31, 2023
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 117-8877
    Biologics Competition Act of 2022


  • March 24, 2023
    Introduced in House


  • March 24, 2023
    Referred to the House Committee on Energy and Commerce.


  • March 31, 2023
    Referred to the Subcommittee on Health.

Health

Biologics Competition Act of 2023

USA118th CongressHR-1790| House 
| Updated: 3/31/2023
Biologics Competition Act of 2023 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

Bill from Previous Congress

HR 117-8877
Biologics Competition Act of 2022
Mar 24, 2023
Introduced in House
Mar 24, 2023
Referred to the House Committee on Energy and Commerce.
Mar 31, 2023
Referred to the Subcommittee on Health.
  • Bill from Previous Congress

    HR 117-8877
    Biologics Competition Act of 2022


  • March 24, 2023
    Introduced in House


  • March 24, 2023
    Referred to the House Committee on Energy and Commerce.


  • March 31, 2023
    Referred to the Subcommittee on Health.
Mariannette Miller-Meeks

Mariannette Miller-Meeks

Republican Representative

Iowa

Cosponsors (4)
Gregory F. Murphy (Republican)Ann M. Kuster (Democratic)Dan Crenshaw (Republican)Nanette Diaz Barragán (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

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