FDA Announces Availability of the Guidance, “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

On December 29, 2016, the U.S. Food and Drug Administration (FDA) announced the availability of the final guidance for industry entitled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.”  FDA finalized the guidance after carefully reviewing comments received on the draft guidance with the same name published in May 2014, and in light of increased regulatory experience and the evolution of the science in biosimilar product development and evaluation.  The final guidance contains the same basic principles from the draft guidance, and includes updated language to address comments received and to provide greater clarity. 

This 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).  This guidance discusses some of the overarching concepts related to clinical pharmacology studies for proposed biosimilar products, approaches for developing the appropriate clinical pharmacology database, and the utility of modeling and simulation for designing clinical studies.  This guidance provides recommendations on how clinical pharmacology studies should be designed in support of biosimilar product applications.  These 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 product.  Clinical pharmacology studies can be instrumental in addressing residual uncertainty in biosimilarity assessments and can also inform the need for and design of 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.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

Instructions for submitting either electronic or written comments on Agency guidances at any time may be found in the federal register notice for this guidance (http://go.usa.gov/x9Y77).

The “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product” guidance is available at http://go.usa.gov/x9YBx. Please refer to the guidance for more details.