门冬胰岛素生物类似药关键质量属性相似性评价研究

doi:10.19803/j.1672-8629.20250851

中国药物警戒 ›› 2026, Vol. 23 ›› Issue (2): 134-140.
DOI: 10.19803/j.1672-8629.20250851

门冬胰岛素生物类似药关键质量属性相似性评价研究

丁晓丽, 孙悦, 姚尚辰^#, 李晶^*

中国食品药品检定研究院化学药品检定所，国家药品监督管理局化学药品质量研究与评价重点实验室，北京 102629

收稿日期:2025-11-27 出版日期:2026-02-15 发布日期:2026-02-13
通讯作者: ^*李晶，女，博士，主任药师，激素与生物技术药物质量控制研究。E-mail: li_jing@nifdc.org.cn; ^#为共同通信作者。
作者简介:丁晓丽，女，硕士，副研究员，胰岛素类药物质量控制研究。
基金资助:
国家重点研发计划（2021YFF0600804）

Similarity Evaluation of Critical Quality Attributes of Insulin Aspart Biosimilars

DING Xiaoli, SUN Yue, YAO Shangchen^#, LI Jing^*

Institute for Chemical Drug Control, National Institutes for Food and Drug Control, NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, Beijing 102629, China

Received:2025-11-27 Online:2026-02-15 Published:2026-02-13

摘要/Abstract

摘要： 目的全面评价研究门冬胰岛素生物类似药关键质量属性的相似性，为相关研发提供关键技术指导，并为监管机构审评审批提供数据支撑。方法基于质量属性风险分级原则，采用多维分析方法，对候选药与参照药在结构表征、纯度及杂质、生物学活性、稳定性等方面进行系统评估。结果候选药与参照药在关键质量属性及稳定性等方面高度相似。结论质量相似性研究是生物类似药整体相似性评价和适应证外推的基础，通过相似性评价研究，为后续非临床及临床研究提供科学依据，促进国内同品种生物类似药的研发上市。

关键词: 门冬胰岛素, 生物类似药, 关键质量属性, 相似性评价, 稳定性, 小鼠

Abstract: Objective To evaluate the similarity in critical quality attributes and stability profiles between the insulin aspart biosimilar candidate and the reference product in order to offer technical guidance for enterprises and provide data for review and approval by regulators. Methods Based on the risk classification principles for critical quality attributes, multidimensional analytical methods were applied to evaluate the candidate biosimilar and the reference product in terms of structural characterization, purity and impurities, biological activity and stability. Results The candidate biosimilar was highly similar to the reference product in critical quality attributes and stability profiles. Conclusion The study of quality similarities underlies the evaluation of overall similarities of biosimilars and the extrapolation of indications. Similarity evaluation can yield scientific evidence to support subsequent non-clinical and clinical studies and facilitate the development and approval of domestic biosimilars of the same variety.

Key words: Insulin Aspart, Biosimilar, Critical Quality Attributes, Similarity Evaluation, Stability, Mice

中图分类号:

R977.15

丁晓丽, 孙悦, 姚尚辰, 李晶. 门冬胰岛素生物类似药关键质量属性相似性评价研究[J]. 中国药物警戒, 2026, 23(2): 134-140.

DING Xiaoli, SUN Yue, YAO Shangchen, LI Jing. Similarity Evaluation of Critical Quality Attributes of Insulin Aspart Biosimilars[J]. Chinese Journal of Pharmacovigilance, 2026, 23(2): 134-140.

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门冬胰岛素生物类似药关键质量属性相似性评价研究

Similarity Evaluation of Critical Quality Attributes of Insulin Aspart Biosimilars

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