The Academy of Managed Care Pharmacy (AMCP) thanks the Department of Health and Human Services, the Department of Labor, and the Department of the Treasure (collectively, the Departments) for the opportunity to provide comments in response to the proposed rule titled “Enhancing Coverage of Preventive Services Under the Affordable Care Act [CMS 9887–P]” published in the Federal Register on October 28, 2024.
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On Aug. 6, AMCP responded to FDA’s draft guidance on considerations in demonstrating biosimilar interchangeability with a biologic reference product. The draft guidance, issued on June 17, describes considerations regarding switching studies which demonstrate interchangeability between biosimilars and their reference biologic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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