Communications for Statistical Applications and Methods

  • 제22권6호
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  • Pages.605-613
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  • 2015
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  • 2287-7843(pISSN)
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  • 2383-4757(eISSN)
한국통계학회 (The Korean Statistical Society)
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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)
  • 투고 : 2015.07.17
  • 심사 : 2015.09.05
  • 발행 : 2015.11.30
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초록

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.

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참고문헌

  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. https://doi.org/10.1080/10543406.2014.948961
  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. https://doi.org/10.1080/10543400903280308
  4. Chow, S. C. and Liu, J. P. (2009). Statistical assessment of biosimilar products, Journal of Biopharmaceutical Statistics, 20, 10-30. https://doi.org/10.1080/10543400903280266
  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. https://doi.org/10.1002/sim.5571
  6. Dong, X. and Tsong, Y. (2014). Equivalence assessment for interchangeability based on two-sided tests, Journal of Biopharmaceutical Statistics, 24, 1312-1331. https://doi.org/10.1080/10543406.2014.941988
  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. https://doi.org/10.1080/10543406.2014.941987
  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. https://doi.org/10.1002/sim.5570
  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. https://doi.org/10.1002/sim.5582
  12. Kang, S. H. and Kim, Y. (2014). Sample size calculations for the development of biosimilar products, Journal of Biopharmaceutical Statistics, 24, 1215-1224. https://doi.org/10.1080/10543406.2014.941984
  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. https://doi.org/10.1002/sim.5612
  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. https://doi.org/10.1080/10543406.2014.941985
  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
  16. US Food and Drug Administration (2010). Guidance for Industry: Non-inferiority clinical trials, www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm202140.pdf
  17. 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
  18. World Health Organization (2009). Guidelines on evaluation of similar biotherapeutic products, http://www.who.int/biologicals/areas/biological therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf
  19. 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. https://doi.org/10.1080/10543406.2014.941989