Department of Health and Human Services May 14, 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.'' This guidance is intended to assist sponsors in developing a clinical pharmacology program to support a decision that a proposed therapeutic biological product is biosimilar to, that is not clinically meaningfully different from, its reference product. Specifically, the guidance discusses some of 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 trials. This draft guidance is one in a series of guidances that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).