關(guān)鍵詞： Cipla Enbrel 依那西普 生物仿制藥
2013年4月18日訊 /生物谷BIOON/ --印度最大的仿制藥生產(chǎn)商之一——西普拉（Cipla）公司宣布,，已在印度市場推出Etacept,，該藥為輝瑞（Pfizer）和安進（Amgen）風濕性疾病重磅藥物——依那西普(etanercept，Enbrel)的首個生物仿制藥,，將由中國上海CP國健藥業(yè)有限公司（Shanghai CP Guojian Pharmaceutical Co）生產(chǎn),。
Etacept的推出,，也標志著Cipla向生物制劑領(lǐng)域的進軍,。Cipla醫(yī)療總監(jiān)Jaideep Gogtay稱：“一直以來,，生物制劑的高成本是一個主要障礙，限制了數(shù)以百萬計患者的負擔能力及藥物的獲取,。公司將以較低的成本（6150盧比,，比Enbrel價格低30%）推出該藥，使印度更多的患者能負擔得起,。”
Enbrel，中文名為恩利（商品名）,，通用名為注射用依那西普（Etanercept ）,，是安進（Amgen）經(jīng)生物工藝生產(chǎn)、由人p75腫瘤壞死因子受體與人免疫球蛋白G1的Fc端連接組成的二聚體融合蛋白,，該藥是全球首個全人源化的,、第一個用于治療類風濕關(guān)節(jié)炎和強直性脊柱炎的可溶性腫瘤壞死因子拮抗劑。除治療類風濕關(guān)節(jié)炎和強直性脊柱炎外,，該藥還已批準用于銀屑病性關(guān)節(jié)炎,、幼年慢性關(guān)節(jié)炎和銀屑病的治療。（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.
(責任編輯：lili.zhao)
