Biologics Competition Act of 2023

Summary

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.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 24 March 2023

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• Introduced in House (PDF)

  Introduced in House · EN · 24 March 2023

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• Introduced in House

  summary · EN · 24 March 2023

  Open at official source

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