Clinical Pharmacology – Biomolecular
Switching studies between a reference product and a biosimilar are key to proving that such switches would remain safe and clinical results would remain unchanged. Before such a determination can be made, a product must first be deemed a biosimilar, and then a determination of interchangeability can follow. FDA has provided guidance on the switching studies necessary to be included in applications for interchangeable products. This presentation will aim to provide a framework and understanding of FDA’s approach to evaluating switching studies aimed to demonstrate interchangeability.