Under the budget resolution adopted on April 10, 2025, the House Energy & Commerce Committee (E&C) is required to submit changes in laws under its jurisdiction to reduce the deficit by at least $880 billion over the fiscal years (FY) 2025-2034.
AMCP Comment Letter on Biosimilar Interchangeability with a Biologic Reference Product
On Aug. 6, AMCP responded to FDA’s draft guidance on considerations in demonstrating biosimilar interchangeability with a biologic reference product. The draft guidance, issued on June 17, describes considerations regarding switching studies which demonstrate interchangeability between biosimilars and their reference biologic products.
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A coalition of 34 scientific and medical organizations led by the American Association of Immunologists and the American College of Physicians released the following statement.
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