FDA Publishes Guidance on Interchangeability of Protein Products
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.
Source: FDA
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
