关键词： Cipla Enbrel 依那西普 生物仿制药
2013年4月18日讯 /生物谷BIOON/ --印度最大的仿制药生产商之一——西普拉（Cipla）公司宣布，已在印度市场推出Etacept，该药为辉瑞（Pfizer）和安进（Amgen）风湿性疾病重磅药物——依那西普(etanercept，Enbrel)的首个生物仿制药，将由中国上海CP国健药业有限公司（Shanghai CP Guojian Pharmaceutical Co）生产。
Etacept的推出，也标志着Cipla向生物制剂领域的进军。Cipla医疗总监Jaideep Gogtay称：“一直以来，生物制剂的高成本是一个主要障碍，限制了数以百万计患者的负担能力及药物的获取。公司将以较低的成本（6150卢比，比Enbrel价格低30%）推出该药，使印度更多的患者能负担得起。”
Enbrel，中文名为恩利（商品名），通用名为注射用依那西普（Etanercept ），是安进（Amgen）经生物工艺生产、由人p75肿瘤坏死因子受体与人免疫球蛋白G1的Fc端连接组成的二聚体融合蛋白，该药是全球首个全人源化的、第一个用于治疗类风湿关节炎和强直性脊柱炎的可溶性肿瘤坏死因子拮抗剂。除治疗类风湿关节炎和强直性脊柱炎外，该药还已批准用于银屑病性关节炎、幼年慢性关节炎和银屑病的治疗。（生物谷bioon.com）
英文原文：Cipla launches Enbrel biosimilar in India
Cipla has launched the first biosimilar of Pfizer and Amgen's rheumatic disorder blockbuster Enbrel in India.
The company will sell its version of Enbrel (etanercept) under the brand name Etacept which will be manufactured by China's Shanghai CP Guojian Pharmaceutical Co. The drug signals Cipla's entry into the biologic segment, it said, "offering an option to patients suffering from rheumatic disorders at a lower cost".
The Mumbai-based group's medical director Jaideep Gogtay said "the higher cost of biologics has been a major hindrance, limiting its affordability and accessibility to millions of patients". He added that introducing Etacept at a lower cost (at 6,150 rupees, 30% less than the innovator product) "will enable access of this drug to a greater number of patients in India".
The recommended dose for adults is 25 mg twice-weekly by subcutaneous injection. Cipla noted that disease-modifying anti-rheumatic drugs (DMARDS) are considered to be the first line of treatment for rheumatic disorders but 40% of patients are not controlled on these therapies.
Strides Arcolab biosimilar JV
Meantime, a unit of India's Strides Arcolab, Agila Biotech has entered into a joint venture with the USA's Pfenex to develop six biosimilars for the global market.
Agila Biotech, which will have a 51% stake in the JV, said the partnership combines Pfenex' "industry-leading expertise in strain engineering and process development" with its own biologics manufacturing and clinical development excellence. The lead product will be a biosimilar of Bayer's multiple sclerosis drug Betaseron (interferon beta-1b) and human clinical trials will begin before the end of the year.
Agila chief executive Anand Iyer said that "a successful foray into the biologics space" for companies like his "hinge not only on building a state-of-the-art infrastructure and strong technical foundation, but also on creative partnerships" such as the one with Pfenex. He added that "this will allow us to not only leverage time and cost advantage of developing products in India and Malaysia but also serve as a gateway to a vast region" in Asia which is "currently underserved as a result of the lack of high-quality, cost-effective biologics".
The products will be manufactured at Agila's state-of-the-art facility being built with partner Bio-XCell at Nusajaya, Johor, Malaysia.
