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美国批准首款生物仿制药物 医疗未来 - 站长搜索
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美国批准首款生物仿制药物 医疗未来

业界动态 2015-03-07 18:03:06 转载来源: 网络整理/侵权必删

美国食品药品管理局(FDA)周五批准了首款生物仿制药,这一决定预计将会催生一个生产廉价版生物技术药物的新行业,从而帮助美国降低其每年高达3750亿美元的药物支出。今日获批的这款药物名为Zarxio,由诺华(公司旗下的Sandoz开发,是安进(Amgen)的白细胞刺激药物Neupogen的仿制版本

美国食品药品管理局(FDA)周五批准首款生物仿制药,这一决定预计将会催生一个生产廉价版生物技术药物的新行业,从而帮助美国降低其每年高达3750亿美元的药物支出。今日获批的这款药物名为Zarxio,由诺华(公司旗下的Sandoz开发,是安进(Amgen)的白细胞刺激药物Neupogen的仿制版本。

类似Neupogen这样的生物技术药物是从活细胞、血液成分和组织中生产或提取出来的复杂药物,是目前市场上最昂贵的药物品种之一。据IMS Health估计,到2016年全球生物技术药物的销售额最高将达到2000亿美元。

诺华一位女发言人表示,新产品的定价将会具有竞争力,但在正式面市之前拒绝透露具体价格。在生物仿制药已获准上市的欧洲主要国家,它们的价格要比正版药物低20%至30%。

标签: 美国 批准 首款 生物 仿制 药物 医疗 未来


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