对生物类似药研发中临床研究的思考

发布时间：2018-07-07 16:21

本文选题：生物类似药 + 临床研究　；参考：《中国药学杂志》2015年06期

【摘要】：目的生物类似药临床相似性研究的目的是评价候选药在临床安全有效性方面与参照药的相似性,这需要设计并开展科学合理的临床试验来证明。本文的目的是提出生物类似药临床试验设计中的关键问题以及解决思路。方法通过对国内外生物类似药研发的现状和多国监管机构的技术指导原则的综合分析,形成生物类似药临床研究的总体考虑要点。结果与结论根据原研产品特征以及药学、非临床比对研究结果,用简化的、少而精的临床试验,来证明候选药与参照药的等效性,以此来桥接原研产品(参照药)已经被认可的有效性和安全性。临床研究设计中,准确的适应证、敏感的受试人群、恰当的评价指标等,都将为生物类似药的最终相似性评价提供有价值的数据和有力证据。
[Abstract]:Objective the purpose of clinical similarity study of biological analogues is to evaluate the similarity between candidate drugs and reference drugs in clinical safety and effectiveness, which needs to design and carry out scientific and reasonable clinical trials to prove the similarity. The purpose of this paper is to put forward the key problems and solutions in the design of clinical trials of biological analogous drugs. Methods based on the comprehensive analysis of the current situation of research and development of biological analogous drugs at home and abroad and the technical guiding principles of many national regulatory bodies, the main points of general consideration for clinical research of biological analogous drugs were formed. Results and conclusion based on the characteristics of the original product and the results of pharmacological and non-clinical comparative studies, a simplified, small and refined clinical trial was used to prove the equivalence between the candidate drug and the reference drug. To bridge the original product (reference drug) has been recognized effectiveness and safety. In clinical research design, accurate indications, sensitive subjects and appropriate evaluation indicators will provide valuable data and strong evidence for the final similarity evaluation of biological analogous drugs.
【作者单位】：国家食品药品监督管理总局药品审评中心;
【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】：R95

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