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S 4332

Medication Competition Act

119th Congress Introduced by Ted Budd and 1 co-sponsor

The bill requires HHS to determine and publish exclusivity periods for first interchangeable biologics and reference products to increase transparency and predictability in biosimi

Introduced in Senate
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Bill Summary · S 4332

Summary of S. 4332 – Medication Competition Act (Senate, 119th Congress)

Date introduced: April 16, 2026
Primary sponsors: Senators Maggie Hassan (D-NH) and Ted Budd (R-NC)

1) Main purpose and intent

The Medication Competition Act aims to require the Secretary of Health and Human Services (HHS) to determine and publish exclusivity periods for licensed biological products. Specifically, it sets forth how exclusivity data should be calculated and disclosed for first interchangeable biological products and reference products, with treatment for products licensed both before and after the date of enactment. The overarching goal is to clarify and standardize the timing of exclusivity periods to promote competition in the biologics market.

2) Key provisions and changes

  • Statutory location amended:

    • The bill amends Section 351(k)(9)(A)(iv) of the Public Health Service Act (42 U.S.C. 262(k)(9)(A)(iv)).

  • New reporting and determination requirements:

    • The Secretary must determine any applicable exclusivity period under subsections (6) or (7) and include those determinations in the published list.

  • Publication requirements:

    • The Secretary must publish an updated list showing exclusivity periods for:
    • First interchangeable biological products (as defined in the bill’s structure and references to exclusivity periods under paragraphs (6) and (7)).
    • Reference products (also tied to exclusivity periods under paragraph (7)).

  • Timing for inclusion on the list:

    • For products licensed on or after enactment:
    • Exclusivity periods must be included not later than 30 days after the earliest date on which an expiration date of such exclusivity can be known under paragraph (6).
    • For products licensed before enactment:
    • Exclusivity periods must be included not later than 30 days after the later of enactment or the earliest date an expiration date under paragraph (6) can be known.

  • Distinction between product types:

    • Exclusion periods for “First Interchangeable Biologic Products” (paragraph (6)) and “Reference Products” (paragraph (7)) are both addressed, with specific timelines for products licensed before and after enactment.

  • Two grouped timelines:

    • For new (post-enactment) products:
    • Interchangeable products: publication of applicable exclusivity period within 30 days after the earliest known expiration date.
    • Reference products: publication of expiration date for exclusivity period under paragraph (7) within 30 days after licensure.
    • For pre-enactment products:
    • Exclusion periods must be published within 30 days after enactment or the earliest known expiration date under paragraph (6) (whichever is later) for interchangeable products.
    • Exclusion periods under paragraph (7) for reference products must be published within 2 years after enactment for products licensed before enactment.

3) Who or what would be affected

  • Biological products licensed under the Public Health Service Act (42 U.S.C. 262) would be subject to determination and publication of exclusivity periods.
  • Stakeholders include:
    • Pharmaceutical and biotechnology sponsors seeking market exclusivity for biologics and their interchangeable versions.
    • Healthcare providers and payers that rely on clear exclusivity timelines for planning competition, biosimilar launches, and pricing.
    • Patients who may benefit from enhanced competition among biologics and potential price effects.
    • Federal and state policymakers and regulators who use the published exclusivity information for oversight and policy decisions.

4) Procedural and timeline aspects

  • Reference to enforcement mechanism: Requires the Secretary of Health and Human Services to determine and publish exclusivity periods and to include them in a listed publication after licensure dates.
  • Enactment timing: The exclusivity determination timelines differ for products licensed before vs. after enactment.
  • Publication deadlines:
    • Post-enactment products: within 30 days after expiration dates become knowable under paragraph (6) or licensure, depending on the category.
    • Pre-enactment products: within 30 days after enactment or the latest applicable date when the expiration date can be known (for interchangeable and reference products) and a special two-year window for reference products with respect to pre-enactment licenses.
  • Administrative scope: The bill focuses on listing and timing, not on establishing new exclusivity periods themselves, but rather on ensuring determinations are made and disclosed.

Overall assessment

S. 4332 seeks to increase transparency and predictability around exclusivity periods for biologics and interchangeable biosimilars by requiring formal determinations from HHS and timely publication. It emphasizes post-licensure timing for when exclusivity information becomes publicly available, with explicit deadlines that vary depending on whether a product is licensed before or after enactment.

Compiled from official sources — confirm details with the bill’s official record.

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