PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 00 · 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.
People & committees
Rep. Miller-Meeks, Mariannette [R-IA-2] · R–IA
Legislative record
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Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
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No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Jan 3, 2025. Consult Congress.gov for the current record.
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