WHO及世界各国生物相似物的命名原则

生物相似物的命名是目前国际上的一个热点及难点课题。本文研究对比了WHO、世界各国药品管理机构和医药产业界对这一课题的研究进展。探讨了如何建立有利于我国生物医药产业发展并与国际接轨的药品通用名命名系统。

At present,the INN nomenclature scheme for biosimilars is an international challenge.The advances in the naming policy development of WHO,national regulatory agencies and the biotech industry were studied.The establishment of domestic naming policy identical to the international ones was discussed,which should promote the biotech industry.It was proposed that the agencies should assign the biosimilars with generic names.It may be an interim measure to prescribe by the nonproprietary name accompanied with the trade name.