[关键词]
[摘要]
对生物类似药名称进行规范管理不仅有利于医生处方和患者用药的准确性,更重要的是利于药品上市后不良反应的可追溯。对美国、欧洲、日本、韩国等国家或地区以及WHO生物类似药命名方式、命名技术要求进行比对研究,尽管各国生物类似药的命名方式有所不同,但"可区分"是各国共同遵循的原则。在对比研究的基础上,结合我国命名、处方管理相关要求、问卷调研和专家研讨,提出完善我国生物类似药命名原则的建议。
[Key word]
[Abstract]
The standardized management of the names of biosimilar drugs is not only conducive to the accuracy of doctors' prescriptions and patients' medication, but more importantly to the traceability of adverse reactions after the drug is put on the market. In this paper, the naming methods and technical requirements of biosimilar drugs in countries such as the United States, Europe, Japan and South Korea as well as WHO are studied. Although the naming methods of biosimilar drugs in different countries are different, it is a common principle for all countries to distinguish them. On the basis of comparative study, combined with China's naming and prescription management related requirements, questionnaire survey and expert discussion, this paper puts forward suggestions to improve the naming principles of biosimilar drugs in China.
[中图分类号]
[基金项目]