Biologics Competition Act of 2022

Summary

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.

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Timeline

1. 19 September 2022

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 19 September 2022

   Introduced

   Introduced in House

   Source: IntroReferral

3. 19 September 2022

   Introduced

   Introduced in House

   Source: IntroReferral

4. 20 September 2022

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 19 September 2022 · Official file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 19 September 2022

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 19 September 2022

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 19 September 2022

  Open at official source

Sponsors

• Rep. Miller-Meeks, Mariannette [R-IA-1] · R · Sponsor
• Rep. Murphy, Gregory F. [R-NC-3] · R · Sponsor
• Rep. Barragán, Nanette Diaz [D-CA-44] · D · Sponsor
• Ann Kuster · D · Sponsor
• Stephanie Bice · R · Cosponsor
• · hsif00 · Standing

Related records

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