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

Wooyoung Shin, Seung Ho Kang

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)227-239
Number of pages13
JournalJournal of Biopharmaceutical Statistics
Volume26
Issue number2
DOIs
Publication statusPublished - 2016 Mar 3

All Science Journal Classification (ASJC) codes

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

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