治疗用生物制品上市后变更的药学可比性研究

Overview of post-approval change and CMC comparability assessment of therapeutic biological products

生物制品生产工艺的变更需进行可比性研究以证实变更未对产品的安全性、有效性和质量可控性产生影响。近年来,国内已上市的生物制品变更申请逐渐增多,而国内对于生物制品上市后生产变更研究缺乏相关的具体技术指南,许多药品生产企业因研究理念和方法存在问题而致使其提交的资料难以通过审评。本文主要介绍已上市治疗用生物制品发生生产变更时需进行的药学可比性研究的一般原则,也可为其他生物制品进行生产工艺变更研究时提供参考。

Changes in manufacture of biological product may necessitate an assessment of comparability to ensure that these changes have not affected the safety, identity, purity, or efficacy of the products. The lack of the guideline of comparability assess- ment for the post-approval change of the therapeutic biological products brings the obstacle for the drug manufacture and regulation. This paper introduced the element of the international guideline, and explored how to make a proper CMC （chemical, manufacture and control） comparability assessment combined with the case study in the drug evaluation process.