生物类似药临床相似性比较试验设计和评价的思考

发布时间：2018-03-31 14:57

  本文选题：生物类似药　切入点：临床相似性标准　出处：《中国药学杂志》2015年06期

【摘要】：目的探讨生物类似药临床相似性比对试验设计的关键考虑要素及结果评价标准。方法检索、调研国外生物类似药指导原则及临床相似性评价相关文献进展,通过案例分析并与生物制药行业研发者、临床及统计学专家共同研讨等方法,形成对生物类似药临床相似性评价的思考。结果与结论生物类似药临床相似性评价的标准应基于产品特异性制定。对于不同的生物制品,在充分了解原研产品质量、有效性、安全性特征的基础上,找到合适的研究人群、终点及等效/非劣效界值至关重要。临床相似性评价标准中应考虑引入参照药自身临床应答变异、受试者临床疗效变异等因素设定界值,并在临床相似性比对试验中进行直接对比评估,从而全面评价临床相似性。
[Abstract]:Objective to explore the key factors and criteria for evaluating the clinical similarity of biological analogues. Methods to search and investigate the relevant literature on the evaluation of clinical similarity and the guiding principles of biological analogues in foreign countries. Through case studies and discussions with R & D, clinical and statistical experts in the biopharmaceutical industry, Results and conclusion the criteria for clinical similarity evaluation of biological analogues should be based on product specificity. For different biological products, the quality and effectiveness of the original products should be fully understood. On the basis of the safety characteristics, it is important to find the appropriate population, the end point and the equivalent / non-inferiority threshold. The clinical response variation of the reference drug itself should be considered in the clinical similarity evaluation criteria. The clinical efficacy variation and other factors were determined and evaluated directly in the clinical similarity comparison test, so as to evaluate the clinical similarity comprehensively.
【作者单位】： 国家食品药品监督管理局药品审评中心;
【基金】：国家科技重大专项“重大新药创制”课题资助项目(项目编号2015ZX09501008)
【分类号】：R96
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本文编号：1691226