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India could hit Roche and BMS with compulsory licences

Generic versions of Herceptin, Sprycel and Ixempra may reach market before patent expiration

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Generic versions of three big-selling cancer drugs could soon be available in India before their patents expire.

According to local newspaper reports, the Department of Pharmaceuticals is considering introducing 'compulsory licences' for Roche's breast cancer treatment Herceptin (trastuzumab), as well as Bristol-Myers Squibb's leukaemia medicine Sprycel (dasatinib) and its chemotherapy Ixempra (ixabepilone).

The first compulsory licence in India was introduced last year for Bayer's liver cancer drug Nexevar (sorefinib), allowing Natco Pharma to sell a copy of the treatment that was 95 per cent cheaper than the original.

The licence effectively overturns a drug's patent by letting other companies make versions of a patented product if the government rules that the medicine is not sold at a "reasonable affordable price”.

It is described by the Indian patent office as an "involuntary contract between a willing buyer and an unwilling seller imposed and enforced by the State".

According to the Indian Express, Herceptin, Ixempra and Sprycel cost 50,000 rupees (€687), 70,000-80,000 rupees (€961 to €1,098) and 15,000 rupees (€206) respectively for a month's dosage.

The Department of Pharmaceuticals didn't comment on what these prices may be reduced to, although Nexavar is now available at 8,880 rupees (€120) for a month's worth of pills when it was previously sold by Bayer for more than 290,000 rupees (€4,000) per month.

Roche and BMS have both, separately, tried to minimise the chances of losing patent protection by reducing the cost of two of the at-risk drugs, but Dr Shyam Aggarwal, a consultant oncologist at Sir Ganga Ram Hospita, told the Indian Express the companies hadn't gone far enough. 

“Even after the recent cut in the prices of Trastuzumab and Dasatinib, they are still way too expensive for the common man," he said.

“It is a very good move and will not just benefit Indians but possibly also bring down cancer drug prices in countries where the pharma market is not controlled by the US and western European nations.”

Both pharma companies were tight-lipped about the matter, with a Roche spokesperson commenting: “We are aware of the article in Indian Express, but cannot confirm or comment on its content. Roche has taken steps to increase access to a number of our drugs in India, including Herceptin. This includes a local price structure and the involvement of a local manufacturing partner.”

A BMS spokesperson said: "Bristol-Myers Squibb has no information about any such action by the Indian government and therefore cannot comment on the [Indian Express] article."

15th January 2013

From: Sales



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