2015年2月26日讯 /生物谷BIOON/ --Celltrion在欧洲12个国家新推出世界上首个单克隆抗体生物类似药Remsima™，目前共在31个国家获得批准，用于自身免疫疾病的治疗。
Celltrion医疗保健今天宣布在欧洲12个新市场正式推出Remsima™（英利昔单抗的类似药），包括：奥地利，比利时，丹麦，法国，德国，希腊，意大利，卢森堡，荷兰，西班牙，瑞典和英国。
Celltrion公司开发的Remsima™，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。Remsima™是做用于肿瘤坏死因子（抗TNF）的单克隆抗体，可以减少炎症和缓解相关疾病的症状。
Ramón y Cajal 大学医院的胃肠病专家Antonio López-SanRomán医生说：“这是让人振奋的消息，整个欧洲的克罗恩和溃疡性结肠炎疾病患者现在有了额外的治疗选择-Remsima™。它已经在世界各地得到证明，并且Remsima™生物类似药的出现可以为医疗系统节约大量的资金”。
尽管生物制剂已经对患者有积极的治疗效果，但这种药物高昂的成本却对医疗系统造成了相当大的负担，并且也限制了患者的使用。生物类似药有潜力降低医疗服务的成本，尤其是用于长期治疗。生物类似药有助于更多患者得到更及早的治疗。
Celltrion医疗保健已公布的数据证明了在法国、意大利和英国，使用Remsima™治疗患者可以成功节省医疗支出。根据西班牙巴塞罗那举办的第十届European Crohn’s and Colitis Organisation’s (ECCO)年度会议上的预算影响分析报告，预计五年共能为这三个国家节省从7600万到3.36亿欧元不等的费用。人们希望在2007年和2020年之间，欧洲生物类似药能够为医疗系统节省118亿到334亿欧元的费用。其中预计最大的节约发生在法国、德国和英国，而且，单克隆抗体生物类似药有望贡献最大的节省额度，预计在18亿到204亿欧元之间。
Celltrion医疗保健的总裁Stanley Hong博士，说：“自身免疫性疾病能对人们的生活产生破坏性的影响，所以我们非常自豪，Remsima™是可以为整个欧盟的病人，提供一个更便捷的治疗方案来控制他们的疾病。 “
临床试验证明了Remsima™和其参照品Remicade在质量、安全性和有效性的可比性。 Remsima™2013年9月10日获得EMA的上市许可 ，目前正接受美国食品和药物管理局FDA的评审。
英文原文
Celltrion launches world’s first biosimilar monoclonal antibody Remsima™ in 12 new European markets-
Now available in 31 countries for the treatment of autoimmune diseases
Business Wire Celltrion
9 hours ago
Celltrion Healthcare has today announced the launch of Remsima™ (infliximab) in 12 European markets： Austria， Belgium， Denmark， France， Germany， Greece， Italy， Luxembourg， the Netherlands， Spain， Sweden and the UK.
Remsima™， developed by Celltrion， Inc.， is the world’s first biosimilar monoclonal antibody (mAb) to be approved by the European Medicines Agency (EMA). It is indicated for the treatment of adult and pediatric Crohn’s disease (CD)， adult and pediatric ulcerative colitis， rheumatoid arthritis， ankylosing spondylitis， psoriasis， and psoriatic arthritis.1 Remsima™ is an anti-tumor necrosis factor (anti-TNF) mAb that is used for reducing inflammation and improving other symptoms of the diseases for which it is indicated.1
Dr Antonio López-SanRomán， a specialist in Gastroenterology at the University Hospital Ramón y Cajal， Spain said： “It is encouraging to know that patients across the whole of Europe with diseases like Crohn’s and ulcerative colitis now have an additional treatment option in Remsima™. It has already been used successfully around the world， and the availability of biosimilars such as Remsima™ could lead to cost savings to the healthcare system.”
While biologics have positively impacted patient treatment， the high cost of using such drugs places a considerable burden on healthcare systems and can affect patient access to treatment.2 Biosimilars have the potential to offer cost savings for health services， particularly as they are often used to treat long-term conditions.3 The use of biosimilars may help to increase patient access to treatment and allow patients to be treated earlier in their disease pathway.4
Celltrion Healthcare has announced data demonstrating the healthcare savings achievable by using Remsima™ to treat patients with CD in France， Italy and the UK.5 The budget impact analysis， presented at the European Crohn’s and Colitis Organisation’s (ECCO) 10th annual congress in Barcelona， Spain， shows that total five-year savings across the three countries ranged from €76 million to €336 million.5 Biosimilars are projected to save health systems in Europe €11.8 billion to €33.4 billion between 2007 and 2020， with the biggest savings predicted in France， Germany and the UK.6 Biosimilar mAbs are expected to deliver the greatest savings， ranging from €1.8 to €20.4 billion.
Dr Stanley Hong， President of Celltrion Healthcare， said： “Autoimmune diseases can have a devastating impact on people’s lives so we are proud that Remsima™ is available for patients across the European Union， offering them a more accessible treatment option to manage their disease.”
Clinical trials have demonstrated comparability of Remsima™ in quality， safety and efficacy to its reference medicinal product Remicade.7，8 Remsima™ received marketing authorization from the EMA on 10 September 2013 and is currently under review by the United States Food and Drug Administration.