生物类似药说明书撰写的技术思考  

Technical Consideration on the Label of Biosimilar Products

作　　者：唐崇淇 钱思源[1] 葛玉梅 宋丽娜 徐刚领 赵聪 韩鸿璨 谢松梅[1] TANG Chong-qi;QIAN Si-yuan;GE Yu-mei;SONG Li-na;XU Gang-ling;ZHAO Cong;HAN Hong-can;XIE Song-mei(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家食品药品监督管理局药品审评中心,北京100022

出　　处：《中国药学杂志》2022年第23期1974-1978,共5页Chinese Pharmaceutical Journal

摘　　要：目的探讨生物类似药说明书撰写的技术考虑。方法调研国内外已发布的生物类似药说明书管理和技术要求,对比不同国家在监管方面考虑的异同,通过分析生物类似药本身的研发特点,并结合我国现有的说明书法律框架,形成生物类似药说明书撰写的技术考虑。结果与结论生物类似药通过证明其与参照药具有相似性而支持其上市,因此,生物类似药说明书有效性和安全性信息应主要按照参照药说明书进行撰写。同时,考虑到生物大分子及适应症外推等因素的复杂性,在说明书中标明其为生物类似药、使用商品名加以区分、结合自身研究情况简述其药代、药效和临床比对试验设计和主要研究结果等,将有助于为生物类似药上市后风险控制、安全性监测及临床医生和患者合理用药等提供科学依据。OBJECTIVE To explore the technical considerations on the labels of biosimilar products.METHODS Investigate the guidances of biosimilar labeling at home and abroad,compare the similarities and differences on regulatory considerations in different countries,and form technical considerations on biosimilar labels by analyzing the research and development characteristics of biosimilars and combining with existing Chinese regulatory framework of labels.RESULTS AND CONCLUSION Biosimilars support their marketing by demonstrating their similarity to the reference drug.Thus,the efficacy and safety information of the biosimilars should be written mainly according to the label of reference drug.Meanwhile,considering the complexity of biological macromolecules,marketing comparison studies,and extrapolation of indications,etc.,it is recommended to mark them with a biosimilar statement in the label.Considering the complexity of factors such as biological macromolecules and extrapolation of indications,mark them as biosimilars in the instructions,use trade names to distinguish them,and briefly describe their pharmacokinetics,pharmacodynamics,clinical comparison trial design based on their own research and main research results,which will provide scientific basis for biosimilar post-market risk control,safety monitoring,and rational drug use by clinicians and patients.

关 键 词：生物类似药 说明书 撰写 技术考虑 参照药 

分 类 号：Q511[生物学—生物化学]