The Korean Journal of Applied Statistics (응용통계연구)

The Korean Statistical Society (한국통계학회)
권호 표지
DOI QR코드

DOI QR Code

Statistical Consideration of the Development of Biosimilar Products

바이오시밀러 개발에 필요한 통계방법들에 대한 고찰

  • Kang, Seung-Ho (Department of Applied Statistics, Yonsei University) ;
  • Nam, Ju-Sun (Department of Statistics, Ewha Womans University, Biopharmaceutical Policy Division, KFDA)
  • 강승호 (연세대학교 응용통계학과) ;
  • 남주선 (이화여자대학교 통계학과, 식품의약품안전청 바이오생약국 바이오의약품정책과)
  • Received : 20111200
  • Accepted : 20120100
  • Published : 2012.02.29
Download PDF
⟨ Previous Next ⟩

Abstract

Recent assessments of the biosimilarity of biologic products have received considerable global attention. A clinical trial should be conducted to assess the biosimilarity of a biosimilar product and a innovator biological product. In this paper we will describe several methods for the implementation of clinical trials and statistical analysis, a real international case and related international guidelines.

최근 들어 바이오시밀러에 대한 국내외 관심이 매우 증가하고 있다. 바이오시밀러가 오리지널 생물의약품과 효능과 안전성이 유사함을 보이기 위해서는 최종적으로 임상시험을 수행하여야 한다. 본 논문에서는 이러한 임상시험의 수행과 통계적 분석에 필요한 여러 방법들과 외국의 사례 그리고 관련된 가이드라인들을 살펴볼 것이다.

Keywords

References

  1. 강승호 (2010). <신약개발에 필요한 의학통계학>, 자유아카데미.
  2. 식품의약품안전청 (2009). <동등생물의약품 평가 가이드라인>.
  3. 식품의약품안전청 (2009). 민원설명회, <동등생물의약품(바이오시밀러) 민원설명회>, 2009.7.22.
  4. 식품의약품안전청 (2011). 보도자료, <식약청, 바이오시밀러 허가 지원 프로그램 본격 가동>, 2011.3.4.
  5. Chow, S. C. (2011). Scientific factors for assessing biosimilarity and drug interchangeability of follow-on biologics, The FDA/Industry workshop.
  6. Chow, S. C., Hsieh, T. C., Chi, E. and Yang, J. (2010). 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
  7. Chow, S. C. and Liu, J. P. (2010). Statistical assessment of biosimilar products, Journal of Biopharmaceutical Statistics, 20, 10-30. https://doi.org/10.1080/10543400903280266
  8. EMEA (2008). Assessment report for Filgrastim Ratiopharm.
  9. European Medicines Agency (2006a). Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues.
  10. European Medicines Agency (2006b). Guideline on similar biological medicinal products containing biotech nology-derived proteins as active substance: Quality issues.
  11. European Medicines Agency (2006c). Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues guidance on similar medicinal products containing recombinant erythropoietins.
  12. European Medicines Agency (2006d). Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues guidance on similar medicinal products containing recombinant erythropoietins.
  13. European Medicines Agency (2006e). Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor.
  14. European Medicines Agency (2006f). Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues guidance on similar medicinal products containing recombinant human soluble insulin.
  15. European Medicines Agency (2006g). Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues guidance on similar medicinal products containing recombinant human soluble somatropin.
  16. European Medicines Agency (2007). Draft guideline on similar medicinal products containing recombinant interferon alpha.
  17. European Medicines Agency (2009). Guideline on non-clinical and clinical development of similar biological medicinal products containing low molecular weight heparins.
  18. Fox, A. (2010). Biosimilar mediciens-new challenges for a new class of medicine, Journal of Biopharmaceu- tical Statistics, 20, 3-9 https://doi.org/10.1080/10543400903549892
  19. Hung, H. M., Wang, S. J. and O'Neill, R. (2009). Challenges and regulatory experiences with non-inferiority trial design without placebo arm, Biometrical Journal, 51, 324-334. https://doi.org/10.1002/bimj.200800219
  20. ICH E9 (1998). Note for Guidance on Statistical Principles for Clinical Trials.
  21. ICH E10 (2001). Choice of Control Group and Related Issues in Clinical Trials.
  22. Kang, S.-H. and Yi, T. (2010). Strength of evidence of non-inferiority trials - The adjustment of the type I error rate in non-inferiority trials with the synthesis method, Statistics in Medicine, 29, 1477-1487.
  23. Tsong, Y. (2007). The utility of active controlled noninferiority/equivalence trials in drug development, International Journal of Pharmaceutical Medicine, 21, 225-233. https://doi.org/10.2165/00124363-200721030-00005
  24. US FDA (2010). Non-Inferiority Clinical Trials. Draft Guidance.
  25. WHO (2009). Guidelines on evaluation of similar biotherapeutic products.