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Updated: Apr 21, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Statistical assessment of biosimilarity based on the relative distance between follow-on biologics for binary
Wooyoung Shin1, Seung-Ho Kang1
1a Department of Applied Statistics , Yonsei University , Seoul , Korea.
Abstract:
A new three-arm parallel design was recently proposed to investigate the biosimilarity between a biological product and a reference product by using the relative distance. The purpose of this article is to extend their results to binary endpoints for three popular metrics: the risk difference, the log relative risk, and the log odds ratio. The relative distances based on the three metrics are defined, and corresponding test procedures are developed. The type I error rates and powers are investigated theoretically and empirically.
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