关于生物类似药研发与评价的思考
发布时间：2018-10-17 14:30
【摘要】：目的探讨生物类似药研发评价的相关问题。方法结合《生物类似药研发与评价技术指导原则》(试行)(以下简称《指导原则》)的起草工作,从生物类似药的起源、现行法规中相关内容、对于生物类似药的理解、生物类似药的研发评价思路、研发与评价的问题与难点等方面探讨交流生物类似药及候选药的内在特性与研发风险。结果与结论建议参照国内颁布的《指导原则》设计适宜的比对性研究,选择适宜的研发路径,评估论证研发工艺、生产规模、研究批次的代表性及合理性,清醒认识比对研究中的技术要求、相似性评判的难度和复杂性,慎重选择和开发生物类似药。
[Abstract]:Objective to explore the related problems in the research and development evaluation of biological analogues. Methods combined with the drafting of the Technical guidelines for the Development and Evaluation of Bio-analogous drugs (hereinafter referred to as "the guiding principles"), from the origin of Bio-analogous drugs, the relevant contents of current laws and regulations, and the understanding of Bio-analogous drugs, This paper discusses the inherent characteristics and R & D risks of the communication of biological-analogous drugs and their candidates from the aspects of the ideas of R & D evaluation, the problems and difficulties of R & D and evaluation of biological-analogous drugs. Results and conclusion it is suggested to design appropriate comparative research, select appropriate R & D path, evaluate R & D process, production scale, representativeness and rationality of R & D batch according to the guidelines issued in China. We should be aware of the technical requirements of comparative study, the difficulty and complexity of similarity evaluation, and carefully select and develop 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(2015ZX09501008)
【分类号】：R95
，
本文编号：2276981
[Abstract]:Objective to explore the related problems in the research and development evaluation of biological analogues. Methods combined with the drafting of the Technical guidelines for the Development and Evaluation of Bio-analogous drugs (hereinafter referred to as "the guiding principles"), from the origin of Bio-analogous drugs, the relevant contents of current laws and regulations, and the understanding of Bio-analogous drugs, This paper discusses the inherent characteristics and R & D risks of the communication of biological-analogous drugs and their candidates from the aspects of the ideas of R & D evaluation, the problems and difficulties of R & D and evaluation of biological-analogous drugs. Results and conclusion it is suggested to design appropriate comparative research, select appropriate R & D path, evaluate R & D process, production scale, representativeness and rationality of R & D batch according to the guidelines issued in China. We should be aware of the technical requirements of comparative study, the difficulty and complexity of similarity evaluation, and carefully select and develop 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(2015ZX09501008)
【分类号】：R95
，
本文编号：2276981
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