Today, FDA released a Final Guidance for Industry: “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.” The guidance provides information about the overarching concepts related to clinical pharmacology studies for biosimilar products, approaches for developing the appropriate clinical pharmacology database, and the utility of modeling and simulation for designing clinical studies. In addition, this final guidance provides information to help sponsors design clinical pharmacology studies in support of biosimilar product applications. These studies are part of a stepwise approach to demonstrating biosimilarity between a proposed biosimilar product and the reference product. Clinical pharmacology studies build upon the foundation of comparative analytical studies and normally are a critical part of demonstrating that there are no clinically meaningful differences between the proposed biosimilar product and the reference. These studies can be instrumental in addressing residual uncertainty in biosimilarity assessments and can also inform the need for and design of any necessary subsequent clinical studies to address remaining uncertainties.
We encourage sponsors to discuss the crucial aspects of their clinical pharmacology development plan with the FDA in the early stages of the biosimilar development program.