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迈兰-百康赫赛汀生物仿制药Hertraz获印度批准

来源:生物谷 2013-11-26 07:35

2013年11月26日讯 /生物谷BIOON/ --全球最大仿制药生产商之一迈兰(Mylan)11月25日宣布,与合作伙伴印度百康(Biocon)合作开发的曲妥珠单抗(trastuzumab)生物仿制药,已获得了印度药品管理总局(DCGI)的批准。Mylan拟以品牌名Hertraz销售其trastuzumab产品,该药为罗氏(Roche)重磅药物赫赛汀(Herceptin,通用名:trastuzumab,曲妥珠单抗)的生物仿制药,适应症为HER2阳性乳腺癌的治疗。

这是Hertraz获得的全球首个监管批准。Mylan计划于2014年年初在印度推出该产品,为印度的患者提供可负担得起的高质量药品。随着该公司进军肿瘤和重症监护领域,Hertraz的商业化推出,将进一步扩大Mylan在印度的商业存在。

Mylan拥有trastuzumab生物仿制药在美国、加拿大、日本、澳大利亚、新西兰、欧盟、欧洲自由贸易联盟国家和独家商业化权利。在印度,Mylan与Biocon共同拥有trastuzumab生物仿制药的商业化权利。

根据IPSOS,截止2012年12月31日,trastuzumab在印度的销售额约为2100万美元。

曲妥珠单抗(trastuzumab)是Mylan和Biocon正在合作开发并旨在推向全球市场的5大生物制品之一,其他4种产品分别为:聚乙二醇化非格司亭(PEG-filgrastim)、贝伐单抗(Bevacizumab)、阿达木单抗(Adalimumab)、依坦西普(Eternacept),分别对应罗氏(Roche)的Neulasta、安维汀(Avastin)、雅培(Abbott)的Humira和辉瑞(Pfizer)的Enbrel。在未来很长一段时期内,这些产品将成为Mylan的一支全球增长驱动力。

Mylan和Biocon于2009年签署合作协议,共同开发5种生物仿制药,主要针对癌症和关节炎的治疗。Biocon于2012年透露,双方合作开发的生物仿制药将带来巨大利润,该公司发言人指出,预计到2015年,通过销售生物仿制药,该公司有望获得约330亿美元的巨大收入。(生物谷Bioon.com)

英文原文:Mylan-Biocon Receive First Indian Biosimilar Regulatory Approval for Herceptin?

PITTSBURGH, Nov. 25, 2013 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its partner Biocon has received approval for a Mylan-Biocon trastuzumab product from the Drug Controller General of India. This is the first regulatory approval for a Mylan-Biocon developed biosimilar product. The product is a biosimilar to Roche's Herceptin?, indicated for the treatment of HER2 overexpressing breast cancer. Mylan intends to market its trastuzumab product under the trade name Hertraz.

Mylan CEO Heather Bresch commented, "This regulatory achievement marks another Mylan first and underscores our commitment to, and confidence in, our biologic development program with Biocon and our belief that these products will become a global growth driver for Mylan over the long-term. We expect to launch our trastuzumab product in India early next year, marking our first launch of a biologic, and we look forward to bringing a high quality, affordable product to patients in India who need it. This launch also further strengthens our expanding commercial presence in India, as we enter the oncology and critical care segments."

Trastuzumab is one of the five biologic products Mylan is developing in partnership with Biocon for the global marketplace. Mylan has exclusive commercialization rights for biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries and co-exclusive commercialization rights with Biocon for product in India. Mylan expects to launch trastuzumab in India early in 2014.

According to IPSOS, trastuzumab had sales in India of approximately $21 million for the 12 months ended Dec. 31, 2012.

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