从国际非专利名称纵观全球生物药发展

生物药(bio-therapeutics)是指采用生物技术制备的、临床上用于疾病治疗的大分子生物制品,具有结构复杂、异质性高等特点,科学严谨的生物药通用名命名,是区分生物药物质基础的主要依据,也是药品生命周期管理的重要基础。世界卫生组织(World Health Organization,WHO)协调建立的国际非专利名称(International Nonproprietary Names,INN)是全球药物命名的标准化体系。从INN的起源,以及生物药INN的类别、发生与发展为主线,以较为详实的数据统计和分析,呈现了全球生物药的衍化进程,从不同的角度纵览生物药技术发展历程,对生物药的研发设计、技术标准及监管策略的考量均具有一定的参考意义。

A Review of the Global Bio-Therapeutics Development Process from the Perspective of International Nonproprietary Names

Bio-therapeutics refer to the macromolecular biological products prepared by biotechnology and applied in disease treatment. Because of their high complexity/heterogeneity on aspects of structure and activity, the scientific and rigorous generic names for bio-therapeutics are fundamental for identifying effective drug substances and regulating their life cycle. The International Nonproprietary Names (INN) Program was established by the World Health Organization (WHO) and coordinated to be a global standardization system for assigning nonproprietary names to medicinal substances.The origin and development of the INN system in particular the biologics INN system were introduced, the INN categories, substances and marketing situation were also illustrated to reflect the development trend of bio-therapeutics. Through detailed data analysis, the development process of global bio-therapeutics as well as related bio-technology were presented and reviewed from multiple perspectives, which could be harnessed as important reference significance for the R&Ds, technical standards, clinical applications and regulatory strategy considerations.