A Tolerance Interval Approach to Assessing the Biosimilarity of Follow-On Biologics

Chen, Chi-Tian; Tsou, Hsiao‐Hui; Lai, Yi-Chun; Chang, Wan-Jung; Liu, Jung-Tzu

doi:10.1080/19466315.2017.1323669

Cited by 3 publications

(3 citation statements)

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“…Various statistical tests to assess biosimilarity have been proposed (Chen et al, 2017;Shin and Kang, 2016;Lu et al, 2014;Zhang et al, 2014;Yang et al, 2012;Kang and Chow, 2013). Kang and Chow (2013) considered statistical tests based on the ratio estimator and linearization method in a three-arm parallel design to determine biosimilarity between reference drugs and test drugs for continuous endpoints.…”

Section: Introductionmentioning

confidence: 99%

“…A type I error rate and power are also investigated theoretically and empirically. Chen et al (2017) recently, assessed biosimilarity based on tolerance limits in a two-arm parallel design. The biosimilarity index based on tolerance limits was found to be more stringent and conservative when compared to other moment-based criterion, especially when variance of biosimilar is larger than that of reference drugs.…”

Section: Introductionmentioning

confidence: 99%

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Statistical tests for biosimilarity based on relative distance between follow-on biologics for ordinal endpoints

Yoo

Kim

2020

CSAM

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Investigations of biosimilarity between reference drugs and test drugs required statistical tests; in addition, statistical tests to evaluate biosimilarity have been recently proposed. Ordinal outcome data has been observed in research; however, appropriate statistical tests to deal with ordinal endpoints for biosimilar have not yet been proposed. This paper extends existing design for ordinal endpoints. Using measure of nominal-ordinal association and relative distances between drugs are defined so that testing procedures are developed. Through simulation studies, we investigate type I error rate and power to show the performance of our suggested method. Furthermore, a comparison between the statistical tests and other designs is proviede to show significance of ordinal endpoints.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Statistical tests for biosimilarity based on relative distance between follow-on biologics for ordinal endpoints

Yoo

Kim

2020

CSAM

View full text Add to dashboard Cite

show abstract

“…Some literatures published in recent years to deal with the development of statistical methodology for evaluation of "biosimilarity" between biosimilar products and innovator's biologics [5][6][7][8][9][10][11][12][13][14]. As indicated by Chow et al [7], current regulation for assessment of bioequivalence may be too loose to be applied for assessment of biosimilarity.…”

Section: Introductionmentioning

confidence: 99%