Equivalence Test for Two Emax Curves in Biosimilar Studies
Kerry Barker, Pfizer Inc. *Bo Jin, Pfizer Biotechnology Clinical Development Keywords: Emax Model, Equivalence Testing The 2014 FDA draft guidance of clinical pharmacology data to support a demonstration of biosimilarity to a reference product considers clinical pharmacology studies as a critical part in the clinical evaluations on similarity between a potential biosimilar and the reference product. While bioequivalence approach can be applied to PK similarity assessment in clinical pharmacology studies as indicated in the draft guidance, there remains to be a few unsettled problems to evaluate the similarity in terms of pharmacodynamics activities, specifically, including the problem to demonstrate the similarity on response profiles between two products. In this presentation, we describe a new procedure to test equivalence of two E-max curves which can be applied to both time-response and dose-response similarity assessments. Simulations results will be presented to compare the new procedure to other traditional procedures in terms of both Type I error and power performance. Discussions will also be provided on endpoint and dose selections from E-max response profile to provide sensitive assessment on similarity.
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC