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The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.
FDA released guidance in May 2019 to help sponsors demonstrate that a proposed therapeutic protein product is interchangeable with a reference product when submitting a marketing application or supplement under 351(k) of the Public Health Services Act. The guidance provides an overview of scientific considerations and discusses the type and amount of data needed to support interchangeability.
Specifically, the guidance addresses product-dependent factors such as product complexity and immunogenicity risk. Biosimilar postmarketing data are also discussed. FDA also details considerations for switching studies to support demonstration of interchangeability including study endpoints, study design and analysis, study population, conditions of use, and route of administration. Also discussed in the guidance are the development of presentations for proposed interchangeable products and postmarketing safety monitoring.