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Biologics Competition Act of 2023

H.R. 1790 Rep. Mariannette Miller-Meeks (R-IA-1) In committee
Bill text PDF
  1. Introduced Mar 24
  2. Committee Mar 24
  3. Passed House Next
  4. Passed Senate Not yet
  5. To President Not yet
  6. Law Not yet
Where it stands
In committee, Mar 24, 2023Next: House vote
1307d ago Mar 31, 2023: Referred to the Subcommittee on Health.
Final votes
No roll callsNo recorded vote on this bill yet
Lobbying
1company, 1 filing
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Summary

Biologics Competition Act of 2023

Full summary2 paragraphs

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.

Library of Congress summary, Mar 24, 2023

Summary versions
  • Introduced in HouseMar 24, 2023

Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 27, 2026.