近日，罗氏表示，该公司从印度一家法庭获得禁令，可以禁止仿制药生产商百康与迈兰将其乳腺癌药物赫赛汀仿制药与赫赛汀原研做对照。迈兰与百康共同开发了乳腺癌药物CANMab和Hertraz，新德里高等法院近日做了此项裁决，禁止两家公司在推广旗下赫赛汀仿制药时参照赫赛汀或赫赛汀的生产工艺、安全性、有效性及销售。

在罗氏于去年夏天决定不在印度寻求赫赛汀专利时，印度百康与美国迈兰在印度上市了CANMab和Hertraz，这为仿制药生产商生产更廉价的赫赛汀仿制药铺平了道路。

“罗氏已申请并获得了一项反对迈兰与百康的禁令。这项禁令可以阻止两家公司将其产品与赫赛汀进行对照，”罗氏女发言人SilviaDobry于2月7日的一份电子邮件声明中这样说。她表示，罗氏已采取行动以证明百康与迈兰的产品与赫赛汀相比是否真的具有相似的有效性和安全性。她表示：“不清楚两款产品是否满足生物仿制药的标准。”

百康与迈兰于去年11月份获得印度药品监管机构批准上市赫赛汀生物仿制药。百康在其网站上的一份声明中称该禁令“极度令人震惊，但并不出人意料”，并补充说，罗氏正试图阻止印度患者获得更实惠的曲妥珠单抗（赫赛汀的通用名）。

西方制药公司热衷于踏进印度这个130亿美元的药品市场，但对于该国的知识产权保护水平也表现出担忧。在印度，仿制药占据了药品销售的90%以上。

Wins court battle after claiming Biocon and Mylan had not followed regulatory criteria  

Roche blocks Herceptin biosimilar in India

Wins court battle after claiming Biocon and Mylan had not followed regulatory criteria

Roche has won a last-minute reprieve from biosimilar competition to its breast cancer drug Herceptin in India.

The Swiss pharma major convinced the High Court in Delhi that the data filed in support of the marketing application for Biocon's CANMAb and Mylan's Hertraz (trastuzumab) biosimilar brands may be flawed, rendering their approvals invalid.

Herceptin has been an intellectual property (IP) battleground in India, with threats of compulsory licensing eventually causing Roche to relinquish its patents on the drug in India, clearing the path for lower-cost competition.

Roche argued in the High Court that Biocon and Mylan had not shown that their products were equivalent to Herceptin using criteria laid down in the India's Guidelines on Similar Biologics, which were published in October 2012, and so should not be able to market their products as biosimilar to the original brand.

Specifically, its counsel said that the defendants could not have secured approval via the due process in such a short period of time, so Biocon and Mylan must have filed before the guidelines - and the criteria for equivalency - were published.

The complex nature of biologics means that unlike their small-molecule chemical cousins it is practically impossible to duplicate a drug entirely, as even a single manufacturer's product will exhibit variations between production runs.

Presiding judge Manmohan Singh concurred with Roche's viewpoint, and indicated that Biocon and Mylan should not be able to market their drug by referring to Herceptin until the "requisite approvals" had been granted.

That effectively means that Biocon and Mylan are not blocked from manufacturing their trastuzumab products, but will be unable to market them. The two companies had indicated they would launch their biosimilars this month at a 25 per cent discount to Roche's drug.

In a statement, Roche said it was "seeking to clarify if Biocon and Mylan's products have demonstrated comparable efficacy and safety to our innovator product trastuzumab." A hearing in the case is expected on February 28.

Biocon has estimated that the high price for Roche's drug has meant that the Indian market for trastuzumab is currently tiny, accounting for only around $21m of global turnover of $6.4bn for Herceptin in 2012.

关键词： 罗氏 仿制药 赫赛汀 乳腺癌药物 百康 迈兰

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