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Interchangeability Department of Health and Human Services (HHS)

Goodwin

Biden Administration Proposes Biosimilar Substitution Without Interchangeability

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​​​​​​​The Biden Administration recently released a 2025 Budget Proposal which includes permitting biosimilar substitution without the Food and Drug Administration’s (“FDA”) separate determination of interchangeability. ...more

Venable LLP

Biden FY25 HHS Budget Eliminates the Separate Interchangeability Designation for Biosimilars

Venable LLP on

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. ...more

Goodwin

Recent and Proposed Legislation Affecting Biosimilars

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​​​​​​​Under Section 11403 of The Inflation Reduction Act, effective starting on Monday, October 3, 2022, and for the next five years, Medicare Part B will pay healthcare providers an 8% add-on fee for qualifying biosimilars,...more

Goodwin

President Biden Issues Executive Order Including Provisions To Promote Generic Drug and Biosimilar Competition in the American...

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On July 9, President Biden issued an Executive Order regarding competition in various sectors of the United States economy, including the healthcare market. Among the 72 initiatives set forth in the Order are instructions...more

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