Cell & Gene Therapies (CGT) offer potentially curative treatment to patients with chronic and hereditary conditions but carry high price tags. One proposal to overcome such financing challenges is to create a national risk pool.
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On Aug. 6, AMCP responded to FDA’s draft guidance on considerations in demonstrating biosimilar interchangeability with a biologic reference product. The draft guidance, issued on June 17, describes considerations regarding switching studies which demonstrate interchangeability between biosimilars and their reference biologic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
The Academy of Managed Care Pharmacy (AMCP) thanks the Centers for Medicare & Medicaid Services (CMS) for the opportunity to provide comments in response to Medicare Drug Price Negotiation Program: Draft Guidance, Manufacturer Effectuation of the Maximum Fair Price in 2028 (Draft Guidance). CMS issued this draft guidance to describe the processes and requirements for manufacturer effectuation of the maximum fair price (MFP) in 2028 for selected drugs payable under Medicare Part B and/or covered under Medicare Part D.
The Academy of Managed Care Pharmacy (AMCP) thanks the Department of Health and Human Services (HHS) for the opportunity to provide comments in response to the Request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making (RFI).
Featured News & Resources
See Full CalendarUpcoming Events
AMCP offers a wide variety of educational opportunities, from events and webinars to online training.
