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http://dx.doi.org/10.5351/CSAM.2015.22.6.605

Statistical Assessment of Biosimilarity based on the Relative Distance between Follow-on Biologics in the (k + 1)-Arm Parallel Design  

Kang, Seung-Ho (Department of Applied Statistics, Yonsei University)
Shin, Wooyoung (Department of Applied Statistics, Yonsei University)
Publication Information
Communications for Statistical Applications and Methods / v.22, no.6, 2015 , pp. 605-613 More about this Journal
Abstract
A three-arm parallel design has been proposed to assess the biosimilarity between a biological product and a reference product using relative distance (Kang and Chow, 2013). The three-arm parallel design consists of two arms for the reference product and one arm for the biosimilar product. This paper extended the three-arm parallel design to a (k + 1)-arm parallel design composed of k (${\geq}3$) arms for the reference product and one arm for the biosimilar product. A new relative distance was defined based on Euclidean distance; consequently, a corresponding test procedure was developed based on asymptotic distribution. Type I error rates and powers were investigated both theoretically and empirically.
Keywords
similarity; biosimilar; equivalence trial; delta method;
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1 Chow, S. C. (2013). Biosimilars: Design and Analysis of Follow-on Biologics, CRC Press, Boca Raton, FL..
2 Chow, S. C., Endrenyi, L., Lachenbruch, P. A. and Mentre, F. (2014). Scientific factors and current issues in biosimilar studies, Journal of Biopharmaceutical Statistics, 24, 1138-1153.   DOI
3 Chow, S. C., Hsieh, T. C., Chi, E. and Yang, J. (2009). A comparison of moment-based and probability-based criteria for assessment of follow-on biologics, Journal of Biopharmaceutical Statistics, 20, 31-45.   DOI
4 Chow, S. C. and Liu, J. P. (2009). Statistical assessment of biosimilar products, Journal of Biopharmaceutical Statistics, 20, 10-30.   DOI
5 Chow, S. C., Wang, J., Endrenyi, L. and Lachenbruch, P. A. (2013). Scientific considerations for assessing biosimilar products, Statistics in Medicine, 32, 370-381.   DOI
6 Dong, X. and Tsong, Y. (2014). Equivalence assessment for interchangeability based on two-sided tests, Journal of Biopharmaceutical Statistics, 24, 1312-1331.   DOI
7 Dong, X., Tsong, Y. and Shen, M. (2014). Equivalence tests for interchangeability based on two one-sided probabilities, Journal of Biopharmaceutical Statistics, 24, 1332-1348.   DOI
8 European Medicines Agency (2003). Guideline on comparability of medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CPMP/3797/02), Available from: http://www.ema.europa.eu/docs/en GB/document library/Scientific_guideline/2009/09/WC500003963.pdf
9 European Medicines Agency (2005). Guideline on similar biological medicinal products (CHMP/437/04), Available from: http://www.ema.europa.eu/docs/en_GB/document library/Scientific_guideline/2009/09/WC500003517.pdf
10 Hsieh, T. C., Chow, S. C., Yang, L. Y. and Chi, E. (2013). The evaluation of biosimilarity index based on reproducibility probability for assessing follow-on biologics, Statistics in Medicine, 32, 406-414.   DOI
11 Kang, S. H. and Chow, S. C. (2013). Statistical assessment of biosimilarity based on relative distance between follow-on biologics, Statistics in Medicine, 32, 382-392.   DOI
12 Kang, S. H. and Kim, Y. (2014). Sample size calculations for the development of biosimilar products, Journal of Biopharmaceutical Statistics, 24, 1215-1224.   DOI
13 Li, Y., Liu, Q., Wood, P. and Johri, A. (2013). Statistical considerations in biosimilar clinical efficacy trials with asymmetrical margins, Statistics in Medicine, 32, 393-405.   DOI
14 Lu, Y., Zhang, Z. Z. and Chow, S. C. (2014). Frequency estimator for assessing of follow-on biologics, Journal of Biopharmaceutical Statistics, 24, 1280-1297.   DOI
15 Shin, W. and Kang, S. H. (2014). Statistical assessment of biosimilarity based on the relative distance between follow-on biologics for binary endpoints, Journal of Biopharmaceutical Statistics, Advance online publication. http://dx.doi.org/10.1080/10543406.2014.979195   DOI
16 US Food and Drug Administration (2010). Guidance for Industry: Non-inferiority clinical trials, www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm202140.pdf
17 Yang, L. Y. and Lai, C. H. (2014). Estimation and approximation approaches for biosimilar index based on reproducibility probability, Journal of Biopharmaceutical Statistics, 24, 1298-1311.   DOI
18 US Food and Drug Administration (2012). Scientific consideration in demonstrating biosimilarity to a reference product: guidance for industry, http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf
19 World Health Organization (2009). Guidelines on evaluation of similar biotherapeutic products, http://www.who.int/biologicals/areas/biological therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf