欧盟批准首个生物仿制单抗药物 发布时间：2013-10-16 来源：药品资讯网信息中心9月，Hospira公司的生物仿制药通过了欧盟审批，该药是欧盟批准的首个单克隆抗体类（mAb）生物仿制药物。欧盟委员会（EC）是根据欧洲药品管理局6月底给出的建议，决定批准Hospira公司的药品Inflectra上市的。Inflectra是强生和默克公司的英利昔单抗药物Remicade的生物仿制药。与传统的化学药品不同，生物制剂含有从活组织提取的不能复制的蛋白质。而生物仿制药物难以开发是因为需要通过很多实验来证明药物的有效性。这种英利昔的生物仿制药最初是由韩国Celltrion公司开发的，它是首个通过欧洲药品管理局的生物仿制药监管途径审批的药品。在欧洲开发的生物仿制药物均被视作现有生物药物的替代品。2012年主要用于治疗类风湿性关节炎的英利昔单抗在欧洲销售额达20亿美元。据Hospira公司估计，到2020年生物仿制单抗药在欧洲将累积到204亿欧元的资金，其中法国、德国和英国的累积额预期最高。2009年，Hospira公司与韩国生物制药公司Celltrion公司达成协议，当时Celltrion公司正在开发8种单克隆抗体仿制药物。在协议中，Hospira获得Inflectra在欧洲和独立国家联合体（CIS）国家，美国、加拿大、澳大利亚和新西兰的销售权限，并将在全欧洲对该药实施专利保护。
Hospira Gains First Biosimilar Approval in EU Therapeutic developed with Celltrion will compete with Remicade.MICHAEL FITZHUGH The Burrill Report September 10, 2013"Inflectra is the first of eight biosimilars that Hospira agreed to develop and market with South Korea-based Celltrion in 2009." The European Commission approved Hospira's Inflectra, Europe's first biosimilar antibody for inflammatory diseases, putting it into competition with Janssen's blockbuster Remicade. The medicine will offer doctors, patients, and health systems a more affordable treatment option, says Hospira, though the company did not benchmark its price against Remicade, saying that pricing for it has not been established and may vary by country. Though generic drugs can offer savings of up to 90 percent on the cost of branded equivalents, savings from biosimilars are expected to be in the range of 20 to 30 percent."For over a decade biologic medicines have been pivotal in treating a range of inflammatory conditions, so the granting of marketing authorization in Europe is a major milestone for Inflectra, and for the future of biologic therapy," says Stan Bukofzer, Hospira's corporate vice president and CMO. Inflectra is the first of eight biosimilars that Hospira agreed to develop and market with South Korea-based Celltrion in 2009. Hospira has exclusive rights to market the therapy in Europe, North America, Australia, and New Zealand. The companies agreed to collaborate on manufacturing and supply while independently commercializing any approved biosimilars under each party's own brand name. In June, the European Medicines Agency recommended approval for the Celltrion version of the biosimilar under the name Remsima. Both Remsima and Inflectra contain the same known active substance, infliximab. Following the EMA's recommendation, Beata Stepniewska, acting director general of the European Generic Medicines Association, called it "a key milestone in the history of medicines in the EU." She said biosimilar medicines "provide real opportunities to reduce the cost of treatment with biopharmaceuticals without compromising the quality of healthcare that is delivered." Just like Remicade, Inflectra has been approved to treat rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
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