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Activity Number: 247 - Clinical Trial Design- 2
Type: Contributed
Date/Time: Monday, July 30, 2018 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #330347
Title: Evaluation of Regional Efficacy Equivalence in Developing Biosimilars
Author(s): Ryuji Uozumi* and Shinjo Yada
Companies: Kyoto University Graduate School of Medicine and A2 Healthcare Corporation
Keywords: Biosimilars; Efficacy equivalence; Interval estimation; Multi-regional clinical trials; Pharmacokinetic information; Power prior

Recently, numerous pharmaceutical sponsors have expressed a great deal of interest in the development of biosimilars in anticipation of the impending expiration of a number of patents for biological medicinal products. In this study, we focus on the clinical trial phase in the setting in which the equivalence of both pharmacokinetic (PK) and efficacy parameters should be demonstrated. Although multi-regional clinical trial (MRCT) is usually performed in developing biosimilars, a certain region does not often participate in the MRCT. In consequence, clinical trials are required only in the specific region, i.e., specific-regional clinical trial (SRCT), owing to the requirement by the regulatory agency in the region. In this talk, a statistical procedure will be discussed to evaluate the efficacy equivalence in the SRCT in the development of biosimilars. In the proposed method, utilizing information from the MRCT is performed by incorporating the power prior in accordance with the congruence of the PK parameters between the SRCT and MRCT. The method will be illustrated with clinical trial examples.

Authors who are presenting talks have a * after their name.

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