Njue Catherine
Biostatistics Unit, Centre for Vaccine Evaluation, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Health Canada, 251 Sir Frederick Banting Driveway, Tunney's Pasture, Ottawa, Ontario, Canada.
Biologicals. 2011 Sep;39(5):266-9. doi: 10.1016/j.biologicals.2011.06.006. Epub 2011 Jul 31.
For the purpose of comparing the efficacy and safety of a Similar Biotherapeutic Product (SBP) to a Reference Biotherapeutic Product (RBP), the "Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)" issued by the World Health Organisation (WHO), states that equivalence or non-inferiority studies may be acceptable. While in principle, equivalence trials are preferred, non-inferiority trials may be considered if appropriately justified, such as for a medicinal product with a wide safety margin. However, the statistical issues involved in the design, conduct, analysis and interpretation of equivalence and non-inferiority trials are complex and subtle, and require that all aspects of these trials be given careful consideration. These issues are important in order to ensure that equivalence and non-inferiority trials provide valid data that are necessary to draw reliable conclusions regarding the clinical similarity of an SBP to an RBP.
为比较相似生物治疗产品（SBP）与参比生物治疗产品（RBP）的疗效和安全性，世界卫生组织（WHO）发布的《相似生物治疗产品（SBP）评估指南》指出，等效性或非劣效性研究可能是可接受的。原则上，等效性试验更为可取，但如果有适当的理由，如对于具有较宽安全范围的药品，也可考虑非劣效性试验。然而，等效性和非劣效性试验在设计、实施、分析和解释中涉及的统计学问题复杂且微妙，需要对这些试验的各个方面予以仔细考虑。为确保等效性和非劣效性试验能够提供有效数据，从而就SBP与RBP的临床相似性得出可靠结论，这些问题至关重要。
