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On Aug. 6, AMCP responded to FDA’s draft guidance on considerations in demonstrating biosimilar interchangeability with a biologic reference product. The draft guidance, issued on June 17, describes considerations regarding switching studies which demonstrate interchangeability between biosimilars and their reference biologic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.
Related
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.
The Protecting Pharmacies in Medicaid Act would prohibit the use of spread pricing arrangements in Medicaid programs. Pharmacy benefit managers (PBMs) would be required to pass through to pharmacies the full amount of the money paid to the PBMs by Medicaid programs, except for a fixed administrative fee. The total reimbursement amount will be determined by a survey of national average drug acquisition costs administered by the Department of Health & Human Services.
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