Effects of between-batch variability on the type I error rate in biosimilar development

Junhui Park, Seung Ho Kang

Research output: Contribution to journalArticlepeer-review


Biological products are known to have some between-batch variation. However, the traditional method to assess biosimilarity does not consider such between-batch variation. Beta-binomial models and linear random effect models are considered in order to incorporate between-batch variation for the binary endpoints and the continuous endpoints, respectively. In this article, emphasis is on the beta-binomial models for the binary endpoint case. For the linear random effect models of the continuous endpoint case, we cite relevant references along with conducting some simulation studies. Overall, we show that the type I error rates are inflated when biosimilarity is evaluated by the traditional method, which ignores between-batch variation.

Original languageEnglish
Pages (from-to)323-340
Number of pages18
JournalCommunications in Statistics: Simulation and Computation
Issue number1
Publication statusPublished - 2022

Bibliographical note

Publisher Copyright:
© 2019 Taylor & Francis Group, LLC.

All Science Journal Classification (ASJC) codes

  • Statistics and Probability
  • Modelling and Simulation


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