Statistical Assessment of Biosimilarity Based on the Relative Distance Between Follow-on Biologics for Time-to-Event Endpoints

Taehee Lee; Seung Ho Kang

doi:10.1080/19466315.2020.1721317

Statistical Assessment of Biosimilarity Based on the Relative Distance Between Follow-on Biologics for Time-to-Event Endpoints

Taehee Lee, Seung Ho Kang

Department of Applied Statistics

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

Abstract

The two-arm parallel design that is commonly used to assess biosimilarity has the drawback that it does not take into account the inherent variability within the reference products. The three-arm parallel design was proposed to solve this problem. The purpose of this article was to extend the previous results to the time-to-event endpoints in the exponential model, the Cox proportional hazard model, and the restricted mean survival time. The relative distance is defined, and the corresponding test procedures are developed based on asymptotic theory. The Type I error rates and powers are investigated theoretically and empirically. Supplementary materials for this article are available online.

Original language	English
Pages (from-to)	91-105
Number of pages	15
Journal	Statistics in Biopharmaceutical Research
Volume	13
Issue number	1
DOIs	https://doi.org/10.1080/19466315.2020.1721317
Publication status	Published - 2021

Bibliographical note

Funding Information:
This research was supported by the Basic Science Research Program through the National Research Foundation of Korea (NRF), funded by the Ministry of Education, Science and Technology (2016R1D1A1A09916819).

Publisher Copyright:
© 2020 American Statistical Association.

All Science Journal Classification (ASJC) codes

Statistics and Probability
Pharmaceutical Science

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10.1080/19466315.2020.1721317

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abstract = "The two-arm parallel design that is commonly used to assess biosimilarity has the drawback that it does not take into account the inherent variability within the reference products. The three-arm parallel design was proposed to solve this problem. The purpose of this article was to extend the previous results to the time-to-event endpoints in the exponential model, the Cox proportional hazard model, and the restricted mean survival time. The relative distance is defined, and the corresponding test procedures are developed based on asymptotic theory. The Type I error rates and powers are investigated theoretically and empirically. Supplementary materials for this article are available online.",

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Statistical Assessment of Biosimilarity Based on the Relative Distance Between Follow-on Biologics for Time-to-Event Endpoints

Abstract

Bibliographical note

All Science Journal Classification (ASJC) codes

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