This draft guidance is intended to assist sponsors with the design and use of clinical pharmacology studies to support a decision that a proposed therapeutic biological product is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 required as part of a stepwise approach to developing the data and information necessary 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.
In its final form, this guidance will be one in a series that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). It 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). Some scientific principles described in this guidance may also be informative for the development of certain biological products under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), but no particular relationship between the standards for approval under these separate statutory schemes is implied.