H.R. 8877 · 117th Congress
Biologics Competition Act of 2022
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Never voted on. It didn't reach a floor vote before the 117th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
Miller-MeeksSponsor4 cosponsors · 2 D, 2 R
3 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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.
What it does: CRS summary · Introduced in House · Sep 19, 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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Biologics Competition Act of 2022
Latest action (Sep 20, 2022): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Sep 19, 2022
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.