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
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
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
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