BEBAC  Ing. Helmut Schütz


Draft Guidance for Industry: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

On 14 May 2014 FDA’s Center for Drug Evaluation and Research (CDER) and Center for Bio­logics Evaluation and Research (CBER) published the drafted guidance for a 90-day public consultation period (i.e., until 12 August 2014).

This draft guidance is intended to assist sponsors with the design and use of clinical phar­ma­cology studies to support a decision that a proposed therapeutic biological product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.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit electronic comments on the draft guid­ance by August 12, 2014 to
See also “Tips for Submitting Effective Comments”.


Final guidance published on December 27, 2016.