FDA issued a draft guidance that provides biologic product manufacturers with recommendations on the nature and type of information they should provide FDA to support postapproval manufacturing changes to biosimilar and interchangeable biosimilar products: https://lnkd.in/geDJqBEm
FDA previously provided recommendations for postapproval manufacturing changes to biosimilars as part of a September 2021 final guidance: https://lnkd.in/deYaEcfE. The agency did not include recommendations for postapproval manufacturing changes to interchangeable biosimilars at that time. The agency has since determined the principles that apply to postapproval manufacturing changes to licensed biosimilar products are also relevant to licensed interchangeable biosimilar products and today’s guidance provides recommendations for both.