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首页 » FDA信息 » “意料之外,情理之中?”FDA推迟首个单抗仿制药审评

“意料之外,情理之中?”FDA推迟首个单抗仿制药审评

来源:生物谷 2015-03-02 11:04

2015年3月2日讯/生物谷BIOON/--FDA咨询委员会原定于3月17日对韩国Celltrion公司Remicade(英利昔单抗)的生物仿制药进行评审,现决定予以推迟,并要求Celltrion提供更多药品的相关信息。(相关阅读:Celltrion在12个欧洲国家新上市单抗生物类似药Remsima

FDA表示对Celltrion的单抗生物仿制药CT-P13的评审将会改期,原因是“药物申请需要提供的信息尚不完整”,但对于具体细节,FDA只字未提。

Celltrion也不愿意透露FDA具体要求了哪些信息,只是强调“对于FDA更改药物评审咨询委员会日期,之前也有过先例”。

迄今为止,美国也仅举行过一次生物仿制药的咨询委员会会议,所以判断FDA这次推迟甚平是否有特殊意义还为时尚早。

专利律师Stacie Ropka告诉记者,“对此你不能过多解读。FDA有可能只是简单索要一些额外文件而已”。

当然,对于生物仿制药,很难确定FDA的真实意图。毕竟,这只是FDA第二个同领域的申请,而且对于单抗药物这是破天荒第一次,所以意义重大,谨慎再所难免。

“在过去,FDA也推迟过多次原研生物药物的评审会议时间”,另一个业内专家提到,“推迟会议其实很正常,Cellrion在欧盟提交的分析资料非常详细,而且,这毕竟是美国第一个单抗生物仿制药申请,所以FDA必然需要更多时间来讨论和决定,尤其,未来会有大量Biosimilar分子的申请提交,所以这次也为被当成一个指导案例”。Celltrion也表示会尽全力配合FDA审核公司的Remicade生物仿制药。

CT-P13,分别由Celltrion和Hospira以Remsima和Inlectra为商品名销售,并且去年8月向FDA提交了评审申请。如果获批,Hospira将在美国独家销售该单抗。

就在前几天,Celltrion宣布,在欧洲12个国家新推出Remsima,即CT-P13,这是世界上第一个由欧洲药品管理局(EMA)批准上市的单克隆抗体(mAb)生物类似药,用于治疗成人和小儿的克罗恩病(CD)、溃疡性结肠炎、类风湿性关节炎、强直性脊柱炎和银屑病。该药物在2012年已经在韩国上市,经过临床实验,被验证为同原产品-风湿性关节炎治疗剂 Remicade具有相同的药效,因此 KFDA批准了同Remicade一样的适应症。

生物仿制药的审批法规方面,在欧洲,首个生物类似药于2006年获批,迄今共计已有12种生物类似药在特殊审批框架下获批上市。欧洲于2012年12月制定了针对单抗类产品的具体指南。为获得批准,需要开展研究证明类似药“与参比药物在质量、安全性和有效性方面不存在任何有意义的差异”。申请者还必须制定风险管理计划,以确保产品的长期安全性和有效性,并监测与产品临床使用有关的意外罕见不良事件。

美国在批准生物类似药方面落后于欧洲。2010年3月,在《可支付医保法案》中设立了该类产品特殊批准路径;2012年,美国食品药品管理局(FDA)发布了指导原则草案,旨在帮助生物类似药产品开发商认识到对该类产品的期望,并提供了清晰的批准监管路径。

值得注意的是,前不久,全球知名的生物制药公司Pfizer以170亿美金收购了Hospria,有业内人士分析,此举在一定程度上也是看重了Hospira在生物仿制药领域的能力。(生物谷Bioon.com)

US FDA postpones Celltrion's Remicade biosimilar review meeting

The US FDA has delayed an advisory committee review of Celltrion's Remicade (infliximab) biosimilar after asking the South Korean drugmaker for more information.

The US Food and Drug Administration (FDA) postponed the March 17 meeting of its Arthritis Advisory Committee scheduled last night, explaining that the review of Celltrion's Remicade biosimilar - CT-P13 - would be rescheduled.

The agency said  the postponement was "due to information requests pending with the sponsor of the application" but did not provide details.

Celltrion declined to tell what information the US regulator had asked for, stressing instead that "it is not unprecedented for the FDA to change the date of an Advisory Committee meeting."

To date there has only been one advisory committee meeting about a biosimilar, so it is too early to say if the delay is significant.

Patent lawyer Stacie Ropka from Axinn told us You cannot read too much into it. FDA could simply be looking for additional information."

"And, of course it is particularly difficult to know if it is of particular significance in the biosimilar context. This was only the second application filed with FDA and was the first biosimilar application for a monoclonal antibody."

And meeting dates for originator biopharmaceuticals have been changed in the past. Another industry expert we asked told us "its not unusual for meetings to be postponed."

He added that: "The analytical data in Celltrion EMA submission was very detailed and since this is the first monoclonal antibody in the US it may take longer for the FDA to review, particularly as this will set a precedent for the future molecules considered."

The South Korean firm told us it will work closely with the FDA in its review of biosimilar infliximab and added that the rescheduled meeting will be announced in the Federal Register.

Biosimilar roll out

The drug CT-P13 "which is sold as Remsima elsewhere by Celltrion and as Inflectra by licensee Hospira" was filed for review in the US last August .

Celltrion submitted the Biologics License Application (BLA) together and "if CT-P13 is approved" Hospira will sell the drug in the US.

News of the meeting delay comes at the end of a month of Remsima lanuches by Celltrion's partner Mundipharma, which sells the drug in Germany, Italy, the UK, the Netherlands, Belgium and Luxembourg.

Hospira will sell the drug in Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden as Inflectra.

 

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