【作者】 王佑富； 王旻； 张娟；

【Author】 Youfu Wang;Min Wang;Juan Zhang;School of Life Science & Technology,China Pharmaceutical University;

【机构】 中国药科大学生命科学与技术学院；

【摘要】 随着全球以单克隆抗体为代表的重磅炸弹级生物药物的专利陆续到期,生物仿制药成为医药行业的热点。然而由于单克隆抗体仿制药的特殊性,使得一般的仿制药法规与指导原则不能适用。因此很多国家与地区的药监部门正在积极制定相关的法规与技术指导原则。我国身为仿制药大国,希望能够抓住此次机遇,再次提升本国医药实力。本文从单克隆抗体研发角度对单克隆抗体仿制药的特殊性进行概述,就其目前在国内外发展现状做一简介。更多还原

【Abstract】 With the patent expires of biopharmaceuticals,pharmaceutical companies pay attentions to biosimilar m Abs.Many pharmaceutical companies try to research and develop biosimilar.Because of the particularity of biosimilar m Abs,general generic drug regulations and guidelines can not be applied to biosimilar m Abs.Many countries’ and regions’ regulatory agencies begin to actively engage in the development of biosimilar guidance and documents.As the major country of generic drug,we need to gain the opportunities to be new level.This review focuses on the outline of biosimilar m Abs’ particularity and the recent development status at home and abroad of biosimilar m Abs.更多还原