This 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. This guidance pertains to those products—such as therapeutic biological products—for which pharmacokinetic (PK) and pharmacodynamic (PD) data are needed to support a demonstration of biosimilarity. Specifically, the guidance discusses some of the overarching concepts related to clinical pharmacology testing for biosimilar products, approaches for developing the appropriate clinical pharmacology database, and the utility of modeling and simulation for designing clinical trials.
This guidance is one in a series that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance is intended to assist sponsors in designing clinical pharmacology studies that can support an application submitted under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)) (a 351(k) application) as part of a stepwise approach to support a demonstration of biosimilarity.