To enhance competition for prescription drugs by increasing the ability of the Department of Justice and Federal Trade Commission to enforce existing antitrust laws regarding biologic and biosimilar products, and for other purposes.

United States115th CongressHR-6478House of Representatives
Updated: Jul 27, 2018

Summary

Biosimilars Competition Act of 2018 This bill amends the Public Health Service Act to require a biologic manufacturer and a biosimilar drug manufacturer to provide notification to the Department of Justice and the Federal Trade Commission regarding certain pharmaceutical agreements. The agreements requiring notice are those related to the manufacturer, marketing or sale of the biosimilar product or the reference product. Biosimilars are biological products approved by the Food and Drug Administration based on their similarity to an already-approved biological product.

Bill texts

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Introduced (House)View official text

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Timeline

  1. Referred to the House Committee on Energy and Commerce.

    House of Representatives

  2. Introduced in House

  3. Referred to the Subcommittee on Health.

    House of Representatives

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