目的 生物类似药的研究不同于新药研发的思路和途径,其核心在于强调质量研究上的可比性或相似性,以及临床应用的等效性或非劣效性。生物类似药的质量研究不仅是保障药品安全性、有效性和质量可控的重要工作,而且是决定产品是否可以按照生物类似药的途径上市的前提和基础。方法 通过探讨、研究,明确、规范或在业界达成生物类似药物质量研究要求的共识,是目前探讨的热点。笔者通过参考国外已有相关的指导原则或研究文献,以及笔者在工作中的思考,就重组单克隆抗体生物类似药质量研究方面,提出笔者的一些考虑和建议,主要包括质量研究的主要内容和研究结果的分析与评价。结果与结论 质量研究是开发生物类似药物的基础,重组单克隆抗体是生物类似药物研发的重要产品类别,希望通过本文对重组单克隆抗体生物类似药物质量研究工作的探讨与分析,能为该工作领域的研究者提供参考和借鉴。
Abstract
OBJECTIVE Different from new drug application, research on biosimilar products mainly focuses on similarity in quality as well as equivalence or non-inferiority in clinical application compared to reference products. Quality research on biosimilar products is one of the most important research fields, for not only it is the main work to secure the safety, efficacy and quality of the products, but also it is the key point that would determine whether the products could follow the requirements for development of biosimilar products.METHODS This article discussed the requirements on the topics of research and analysis and evaluation of the RESULTS of quality research of biosimilar products containing recombinant monoclonal antibodies on the basis of relevant guidelines abroad, research papers and authors' working experience. RESULTS AND CONCLUSION Quality study is the foundation of biosimilar products development, and recombinant monoclonal antibody is a main category of biosimilar product. Hopefully, by this article, some references will be provided to the researchers engaged in this field.
关键词
生物类似药 /
重组单克隆抗体 /
质量研究
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Key words
biosimilar /
quality research /
recombinant monoclonal antibody.
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中图分类号：
S859.79
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参考文献
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