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罗氏不会在印度延续Herceptin专利

来源:生物谷 2013-08-19 19:15

2013年8月19日讯 /生物谷BIOON/ --罗氏公司日前宣布将不会在印度寻求延长其专利药物Herceptin的专利保护期。此举将促使印度的仿制药市场加速成熟。不过罗氏公司同时也表示,即使公司放弃了这些专利,短时间内相关仿制药也无法登陆印度市场。

Herceptin是罗氏公司销量第二高的药物,2012年销售额达到62.4亿美元,主要用于治疗乳腺癌。此次罗氏放弃延长Herceptin的有效期多少也出乎市场的预料,不过此举也消除了印度强制中断其专利保护的可能性。与此同时,罗氏公司也早在一年前就开始布局和印度本土医药公司合作推出Herceptin的仿制药版本。(生物谷Bioon.com)

详细英文报道:

Roche ($RHHBY) is throwing in the towel on its IP protection for Herceptin in India. As PharmAsia News reports, the company will give up its patents for Herceptin there, a move that opens it up to biosimilar competition and potentially heads off compulsory licensing in the process. And as Roche points out, giving up these patents doesn't necessarily mean biosimilar versions will spring to market anytime soon.

"While the patent for trastuzumab in India may no longer be in force, it is important to note that there are currently no approved biosimilars of trastuzumab in India," Roche spokesman Daniel Grotzky told FiercePharma in an emailed statement.

The drug for HER2-positive breast cancer is the second-leading product for the Swiss drug giant, with $6.34 billion in 2012 revenue. Herceptin's IP protection was struck down earlier this month by the Kolkata Patent Office, which said the patents hadn't been properly submitted. Now, PharmAsia News says, Herceptin can effectively be made by Indian generic pharma companies 6 years ahead of its scheduled 2019 patent expiration.

But there may not be any coming in the near term. Cipla, an Indian leader in generic cancer drugs, formed a biosimilars partnership in 2010 with its eye on a Herceptin knockoff. But as of February, the World Health Organization (WHO) expressed the belief that Cipla and its Indian counterparts weren't ready to make biosimilar copies. "We support the Indian Government's leadership in establishing a pathway and guidelines for the introduction of biosimilars onto the market that is based on science and is designed to ensure product quality and patient safety," Grotzky said.

Roche's decision may also eliminate the possibility of India granting a compulsory license on the drug now that Herceptin is already open to competition. India last March granted the first compulsory license to local company Natco Pharma on Bayer's kidney drug Nexavar, and one for Herceptin was rumored to have been on the table, PharmAsia News notes.

Roche, like many of its peers, had already seen one of its patents yanked before Herceptin was called into question. Last year, the Swiss drug giant lost a patent fight over its hepatitis C drug, Pegasys. But the Herceptin move was a bit surprising; Roche had teamed up with domestic drugmaker Emcure Pharmaceuticals to produce the drug in India, and a year ago the pair said it would roll out less costly versions of Herceptin as well as MabThera, also known as Rituxan. Recently, Roche said it would be cutting Herceptin prices in India by 31% to $1,366 per month.

 

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