生物类似药质量分析方法研究进展

Development of Analytical Methods for Quality Assessment of Biosimilars

目的:为生物类似药的研发提供参考和借鉴。方法:通过查阅国内外大量文献,结合生物类似药相关法规,重点对生物类似药的理化特性、生物学活性、纯度与杂质、免疫学特性等药学特性进行梳理,并对相关分析方法进行汇总分析。结果与结论:生物类似药的研发需要采用先进的、敏感的技术和方法表征生物类似药的质量属性,评估生物类似药与参照药的生物相似性。通过对生物类似药的药学特性分析方法的相关研究进行综述,为生物类似药的研发和质量控制提供参考和借鉴。

Objective:To provide information and references for the research and development of biosimilars.Methods:Through reviewing a great deal of domestic and foreign literature in recent years,biosimilars’ physics and chemistry characteristics,biological activities,purity and impurity,immunological properties,the current research status and trend in the development of quality analysis methods were summarized and analyzed by combing pharmaceutical regulations of biosimilars.Results and Conclusion:Advanced and sensitive analytical techniques are required for characterizing the biosimilars and assessing similarities between biosimilars and references.This article reviews the recent advances in analytical methods for pharmaceutical properties of biosimilars,thus providing references for biosimilar development and quality control.