我国国家基本药物目录中仿制药参比制剂设立情况研究

On the Establishment of Generic Reference Formulations in China’s National Essential Drug List

目的:研究我国《国家基本药物目录》(以下简称:《目录》)中仿制药参比制剂设立情况,为仿制药参比制剂的遴选提供科学依据。方法:将国家药品监督管理局发布的仿制药参比制剂与《国家基本药物目录》中药品进行匹配,对匹配情况及匹配后特征进行分析。采用描述性分析、卡方检验等方法进行统计学分析。结果:2018年版《目录》中化学药品和生物制品共计417种,其中有112种(27%)无任何对应剂型和规格的参比制剂。在发布的4509种参比制剂中,59%的参比制剂不是基本药物。国内未上市参比制剂具有的剂型和规格数量要多于国内上市的参比制剂(Z=-6.86,p<0.01)。国内上市的682种原研进口参比制剂中,基本药物的比例为13%;国内未上市的3646种原研进口参比制剂中,基本药物的比例为20%。两者差异有统计学意义(χ^(2)=97.7,p<0.01)。结论:参比制剂不断增多,但针对基本药物的参比制剂缺失比例仍较大。参比制剂剂型规格复杂多样,但大部分并未被《目录》囊括。这些特点使基本药物参比制剂的选择和使用面临更大的挑战。

Objective: To study the establishment of generic reference formulations in China’s National Essential Drug List and provide a scientific basis for the selection of generic reference formulations. Methods: The generic reference formulations released by National Medical Products Administration were matched with the drugs in the National Essential Drug List, and the matching situation and post-matching characteristics were analyzed.Descriptive analysis with chi-square test was used for statistical analysis. Results: Total 417 kinds of chemical drugs and biological products were included in the 2018 edition of the National Essential Drug List, of which 112 kinds(27%) did not have any corresponding dosage forms and specifications of reference formulations. Among the 4509 reference formulations released, 59% of them are not essential drugs. The number of dosage forms and specifications of domestic unmarketed reference formulations was significantly greater than the number of domestic marketed reference formulations(Z=-6.86, p<0.01). Among the 682 originally imported reference formulations marketed in China, the proportion of essential drugs was 13%;among the 3646 originally imported reference formulations which have not marketed in China, the proportion of essential drugs was 20%. The difference between them was statistically significant(χ^(2)=97.7, p<0.01). Conclusion: The number of reference formulations is increasing in China, while there is still a large proportion of missing reference formulations for essential drugs. Although dosage forms and specifications of reference formulations are complex and diverse,most of them are not included in the National Essential Drug List. These characteristics lead to greater challenges on the selection and utilization of reference formulations of essential medicines.