重磅!FDA批准美国市场阿达木单抗生物仿制药Amjevita

2016-09-27 佚名 生物谷

美国生物技术巨头安进(Amgen)生物仿制药管线近日在美国监管方面迎来重大喜讯。美国食品和药物管理局(FDA)已批准生物仿制药Amjevita(adalimumab-atto,阿达木单抗)用于艾伯维品牌药Humira(修美乐,通用名:adalimumab,阿达木单抗)全部的适应症。 此次批准,使Amjevita成为美国市场首个Humira生物仿制药,将用于全部7种炎症性疾病的治疗,包括:中度

美国生物技术巨头安进(Amgen)生物仿制药管线近日在美国监管方面迎来重大喜讯。美国食品和药物管理局(FDA)已批准生物仿制药Amjevita(adalimumab-atto,阿达木单抗)用于艾伯维品牌药Humira(修美乐,通用名:adalimumab,阿达木单抗)全部的适应症。

此次批准,使Amjevita成为美国市场首个Humira生物仿制药,将用于全部7种炎症性疾病的治疗,包括:中度至重度类风湿性关节炎(RA)、中度至重度多关节型幼年特发性关节炎(pJIA)、银屑病关节炎(PS)、强直性脊柱炎(AS)、中度至重度慢性斑块型银屑病、成人中度至重度克罗恩病和中度至重度溃疡性结肠炎。

目前,尽管安进自身的几个重磅生物药也正面临着仿制威胁,但该公司也有着雄心勃勃的计划。去年,安进宣布正在开发9个重磅生物药的仿制药,并计划在2017年开始将产品推向市场。安进表示,这些产品最终将带来超过30亿美元的年销售额。

Amjevita便是9个资产中首个获得监管批准的产品,这也标志着该公司作为生物技术领域全球领导者在生物仿制药领域开启的新篇章。

Humira(阿达木单抗)是艾伯维的旗舰产品,该药是全球最畅销的处方药,年销售额接近150亿美元。目前有多家制药公司都在争相开发Humira的生物仿制药。安进于2015年11月底向FDA提交了Amjevita(ABP 501)的生物制品许可申请(BLA)。

Amjevita(ABP 501)的活性成分是一种抗TNF-α单克隆抗体,与adalimumab(阿达木单抗)具有相同的氨基酸序列。ABP 501具有adalimumab相同的药物剂型和剂量。

安进所提交的BLA,纳入了ABP 501的分析、临床及药代动力学数据。在中度至重度斑块型银屑病和中度至重度类风湿性关节炎中开展的III期比较性疗效和安全性研究,将ABP 501与Humira进行了对比。研究结果达到了ABP 501与Humira临床等效性的主要终点,ABP 501的安全性和免疫原性也与Humira相当。支持患者由Humira过渡至ABP 501的数据也已纳入所提交的BLA中。

原始出处:

FDA Approves Amgen's AMJEVITA™ (Adalimumab-Atto) For Treatment Of Seven Inflammatory Diseases


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    2017-05-27 bugit
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    2016-09-29 drwjr
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    2016-09-29 xxxx1054
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