AMCP Comments on PREVENT HPV Cancers Act
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On Aug. 6, AMCP responded to FDA’s draft guidance on considerations in demonstrating biosimilar interchangeability with a biologic reference product. The draft guidance, issued on June 17, describes considerations regarding switching studies which demonstrate interchangeability between biosimilars and their reference biologic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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On September 9, AMCP submitted comments praising CMS’s proposal to cover Digital Mental Health Treatment devices (DMHTs) under Medicare Part B. AMCP urges CMS to use its authority to cover all FDA-cleared, prescription only digital health products and develop appropriate coding and payment methodologies to promote adoption of these innovative technologies.
SB 966, California's PBM reform bill, could reshape pharmacy benefit manager regulation if signed into law. Governor Newsom’s decision is expected by September 30.
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