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从抗CD20单抗探讨我国生物类似药非临床研究与评价的思路 被引量：1

Non-clinical study and evaluation thinking of biosimilar products in China: reviewing the case of anti-CD20 monoclonal antibody
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摘要 CFDA发布《生物类似药研发与评价技术指导原则(试行)》,明确了生物类似药非临床研究和评价中的基本原则。国内外研发生物类似药成为热点,本文结合国内外相关指导原则的要求和国内抗CD20单抗品种的审评,讨论我国生物类似药非临床研究评价的思路。 CFDA has issued the guidance on evaluation of biosimilar products （Trail） to clarify the essen- tial principle of evaluation on non-clinical study of biosimilar products. In this article, taking the relevant guide- lines and reviews of real cases on anti-CD20 monoclonal antibodies as reference, we discuss the thinking of review approach to preclinical evaluation of biosimilar products in China, while development and research on biosimilar products become world-wide hot spots currently.
作者 余珊珊 胡晓敏 王海学 王庆利 于冰
机构地区 国家食品药品监督管理总局药品审评中心
出处 《中国新药杂志》 CAS CSCD 北大核心 2015年第22期2544-2547,共4页 Chinese Journal of New Drugs
关键词 生物类似药 抗CD20单抗 非临床研究 审评 biosimilar products anti-CD20 monoclonal antibodies pre-clinical research evaluation
分类号 R95 [医药卫生—药学]
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参考文献12

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共引文献32

同被引文献10

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引证文献1

中国新药杂志
2015年 第22期

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