抗体类生物类似药命名管理及其影响分析

Analysis of the Management and Influences of the Naming about Biosimilar Antibodies

关键词:  抗体  生物类似药  命名

Key words:  antibody  biosimilar  naming

摘要:

目的 规范我国抗体类生物类似药命名，完善其全生命周期管理体系。方法 深入研究世界卫生组织（World Health Organization，WHO）、欧盟、美国、日本及我国关于抗体类生物类似药的命名要求，分析不同命名方式对药品全生命周期管理的影响。结果 目前，国内外抗体类生物类似药的命名原则不尽相同，但总体遵循WHO的国际非专利药名系统不同的命名方式将对处方安全性、药物警戒、医保准入与支付等方面产生影响。结论 建议药品监管部门逐步与国际接轨，基于国际非专利药名系统并结合我国实际情况尽快出台生物类似药命名相关文件，以明确抗体类生物类似药命名。此外，建议加强药物警戒管理、制定科学审慎的生物类似药医保支付决策，从而构建生物类似药尤其是抗体类药物的全生命周期管理体系。

Abstract:

OBJECTIVE To standardize China's naming of biosimilar antibodies and improve the whole life cycle management system of biosimilar antibodies. METHODS Carried on deep research into the naming principles of World Health Organization(WHO), EU, USA, Japan and China. And analyzed the effects of different naming methods towards drug life cycle management. RESULTS At present, the naming principles of biosimilar antibodies were not the same at home and abroad, but they were based on the international nonproprietary names for pharmaceutical substances(INN) system established by WHO generally. Different naming methods would influence prescription safety, pharmacovigilance, the access and reimbursement of medical insurance. CONCLUSION To be in line with the international standards step by step, it is suggested that the drug regulatory departments shall issue related documents about the naming of biosimilars according to the actual situation of our country as soon as possible, based on the INN system. Thus, the naming principles of biosimilar antibodies will be clear. In addition, to establish the whole life cycle management system of biosimilars, especially the antibodies, it is suggested to strengthen the administration of pharmacovigilance and make scientific and prudent decisions on the reimbursement of medical insurance about biosimilars.