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欧盟批准首个单抗类生物仿制药Inflectra

来源:生物谷 2013-09-11 07:43

2013年9月11日讯 /生物谷BIOON/ --9月10日,全球第二大、亚太最大单抗药物生产企业——韩国生物制品制造商Celltrion,和全球领先注射药物和输液技术供应商Hospira联合宣布,Inflectra(infliximab,英利昔单抗)获得了欧盟委员会(EC)的批准,该药是欧盟获批的首个单抗类(mAb)生物仿制药。Inflectra获批用于炎症性疾病的治疗,包括类风湿性关节炎(RA)、强直性脊柱炎、克罗恩病(CD)、溃疡性结肠炎(UC)、银屑病关节炎(PsA)和牛皮癣。

Inflectra是强生(JNJ)和默沙东(Merck & Co)重磅药物Remicade(类克,infliximab)的生物仿制药,同时也是通过欧洲药品管理局(EMA)生物仿制药监管途径获批的首个单克隆抗体(mAb)。满足欧盟要求的生物仿制药,可作为现有生物制剂的一个治疗选择。2012年,Remicade在欧洲的销售额超过了20亿美元,全球销售额超过60亿美元。

欧洲药品管理局(EMA)和EC通过科学严谨的审查和批准程序,证实了Inflectra与Remicade具有类似的质量、疗效和安全性,将为医生、患者、医疗保健系统提供更实惠的治疗方案,同时也将为欧盟卫生系统提供一个机会,来更有效地管理预算。

Inflectra的获批,是基于全面性临床试验项目中的安全性、有效性、耐受性数据,研究中,Inflectra到达了与Remicade治疗等效性的主要终点。

关于Inflectra:

Inflectra是一种嵌合人鼠单克隆抗体,高亲和结合可溶性和跨膜形式TNFα,阻止其与TNF受体的结合,从而抑制TNFα的生物活性。(生物谷Bioon.com)

英文原文:Europe approves first biosimilar antibody drug

LONDON (Reuters) - The European Commission has approved the first copycat version of an antibody-based drug, clearing the way for increased competition for the makers of multi-billion dollar biotechnology drugs to treat complex diseases.

Tuesday's final green light for Inflectra - which was developed by South Korea's Celltrion and will be marketed by U.S. company Hospira - had been expected following a European Medicines Agency recommendation in June.

Hospira said the drug for treating rheumatoid arthritis and some other conditions would be launched throughout Europe "at the earliest opportunity taking into account any relevant patent protection".

Inflectra is a so-called biosimilar version of Johnson & Johnson and Merck & Co's Remicade.

Unlike traditional chemical drugs, biotech medicines consist of proteins derived from living organisms that cannot be replicated exactly. Biosimilars, therefore, are more difficult to develop and need more tests to prove they work properly.

Until now biotech medicines like Remicade, given by injection or infusion, have been largely immune from generic competition, unlike conventional pills.

But Europe's approval of the Celltrion/Hospira product shows the changing landscape as regulators set out a clearer path for the evidence needed to secure approval of such drugs.

Celltrion said in June it was planning to seek approval in Japan later this year and that an application for U.S. approval is possible in 2015.

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