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ARTICLE · 25 MARCH 2024

Biden FY25 HHS Budget Eliminates The Separate Interchangeability Designation For Biosimilars

Venable LLP
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On March 11, 2024, the White House released President Biden's FY 2025 Department of Health and Human Services (HHS) Budget in Brief, which outlines $130.7 billion in discretionary...

United StatesGovernment, Public Sector
Robert S. Schwartz, Ph.D.
Robert S. Schwartz, Ph.D.

On March 11, 2024, the White House released President Biden's FY 2025 Department of Health and Human Services (HHS) Budget in Brief, which outlines $130.7 billion in discretionary funding for HHS. Included in the budget proposal is a provision that would eliminate the separate biosimilar and interchangeable designations, deeming all approved biosimilars to be interchangeable with their reference product, without the need for switching studies. This change is an attempt to alleviate confusion about safety and efficacy differences between biosimilars and interchangebles that stems from having two separate categories of drugs.

An interchangeability designation allows for automatic substitution at the pharmacy level, subject to State laws. Considering all biosimilars to be interchangeable may increase uptake in the U.S. This change would align the U.S. with other regulatory jurisdictions like the European Union where all biosimilars are considered interchangeable upon

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