关于单抗生物类似药“质量相似性”的思考

刘伯宁,白玉,罗建辉

中国药学杂志 ›› 2017, Vol. 52 ›› Issue (13) : 1194-1200.

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中国药学杂志
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中国药学杂志 ›› 2017, Vol. 52 ›› Issue (13) : 1194-1200. DOI: 10.11669/cpj.2017.13.018
论著

关于单抗生物类似药“质量相似性”的思考

  • 刘伯宁,白玉,罗建辉*
作者信息 +

Biosimilarity Study Regarding Product Quality of Candidate Recombinant Monoclonal Antibodies as Biosimilars

  • LIU Bo-ning, BAI Yu, LUO Jian-hui*
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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 Nowadays, recombinant monoclonal antibodies developed as biosimilar domains in application category for Investigational New Drug in domestic. The quality similarity should be prequalified for candidate drug to be developed as biosimilar. Here, the concept of quality biosimilarity was proposed and discussed from reviewer as well as developer. METHODS The challenge of developing and evaluating biosimilar antibodies was emphasized. Then, the domestic sponsor’s common problems were sorted out and critical quality attributes of some originator antibodies were summarized. Lastly, the reasons of holding letter or case rejected were exemplified and analyzed. RESULTS AND CONCLUSION The sponsor are encouraged to conduct comparing exercise by state-of-art analytical technologies to conform the quality similarity between a proposed biosimilar antibody and the originator product, the reviewers should also be very cautious to assess quality differences. Joint efforts and effective communication from researcher and reviewer are critical for promoting development of domestic biosimilar and addressing the unmet medicine need.

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

Key words

biosimilar antibodies / biosimilarity assessment / quality research / adalimumab / rituximab / cetuximab / trastuzumab / bevacizumab

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刘伯宁,白玉,罗建辉. 关于单抗生物类似药“质量相似性”的思考[J]. 中国药学杂志, 2017, 52(13): 1194-1200 https://doi.org/10.11669/cpj.2017.13.018
LIU Bo-ning, BAI Yu, LUO Jian-hui. Biosimilarity Study Regarding Product Quality of Candidate Recombinant Monoclonal Antibodies as Biosimilars[J]. Chinese Pharmaceutical Journal, 2017, 52(13): 1194-1200 https://doi.org/10.11669/cpj.2017.13.018
中图分类号： R917   

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基金

国家科技重大专项“重大新药创制”课题资助项目(2015ZX09501008)
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