Statistical assessment of biosimilarity based on the relative distance between follow-on biologics for binary endpoints.

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.