FDA Issues New Guidance on Use of Clinical Pharmacology Studies to Show Biosimilarity

The FDA issued a new Guidance today, titled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.”  The Guidance is intended to “assist sponsors with the design and use of clinical pharmacology studies to support a decision that a proposed therapeutic biological product is biosimilar to its reference product.”  As stated in the Guidance, “clinical pharmacology studies play a critical role in the development of biosimilar products. These studies are part of a stepwise process for demonstrating biosimilarity between a proposed biosimilar product and the reference product. These studies may support a demonstration that there are no clinically meaningful differences between the products. These studies may address residual uncertainties that remain after the analytical evaluation, may add to the totality of the evidence supporting a demonstration of biosimilarity, and may also support a selective and targeted approach to the design of any recommended subsequent clinical studies to support a demonstration of biosimilarity.”