关于单抗生物类似药“质量相似性”的思考

发布时间：2018-01-26 06:22

本文关键词： 单抗生物类似药相似性评价质量研究阿达木单抗利妥昔单抗西妥昔单抗曲妥珠单抗贝伐珠单抗　出处：《中国药学杂志》2017年13期 　论文类型：期刊论文

【摘要】：目的单抗生物类似药是目前国内生物制品中申报临床最多的品种。药学研究证实"质量相似性"是其作为"生物类似药"开发的先决条件。如何认识和评价单抗生物类似药的质量相似性,值得工业界和监管方深入研究并广泛讨论。方法本文介绍了工业界开发单抗生物类药的技术难点,以及国内外质量相似性评价的相关指导原则。分析了目前集中申报品种的质控特点,对标准复核常见意见进行梳理,最后对既往此类品种"技术审评未通过"或"发补"原因进行分析。结果与结论应鼓励研发者采用先进、互补方法深入研究候选药与参比药的质量相似性。审评需审慎对待质量研究中出现的"不相似"问题。通过双方共同努力、有效交流,促进国内单抗生物类似药开发,以缓解国内未满足的临床用药需求。
[Abstract]:Objective Monoclonal bioanalogues are the most frequently declared clinical species in domestic biological products. Pharmacological studies have confirmed that "quality similarity" is a "biological analogous drug". Prerequisites for development. How to recognize and evaluate the quality similarity of monoclonal antibodies. Methods the technical difficulties in the development of monoclonal antibodies in industry are introduced in this paper. As well as the domestic and foreign quality similarity evaluation related guiding principles. Analyzed the current centralized declaration of the quality control characteristics of varieties, the standard review of common opinions were combed. Finally, the reasons for the "technical review" or "supplement" of such varieties were analyzed. The results and conclusions should encourage the R & D to adopt the advanced approach. The complementary method is used to study the quality similarity between candidate and reference drugs. The review needs to treat carefully the "dissimilarity" problem in the quality research, and to communicate effectively through the joint efforts of both sides. To promote the development of domestic monoclonal antibody bioanalogues to alleviate the unmet clinical drug demand in China.
【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
【正文快照】： 重组单克隆抗体(含Fc融合蛋白)由于药物靶点明确,临床疗效显著,市场规模巨大,已经成为生物制药研发的热点。随着早期上市“重磅炸弹级”抗体药物(如:修美乐溲、美罗华溲、爱必妥溲、赫赛汀溲、安维汀溲等)专利悬崖的临近,近年来国内外兴起了单抗生物类似药开发的热潮[1]。国际

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