India to issue compulsory license for Herceptin

January 15, 2013 7:23 AM


In a move that will benefit thousands of cancer patients but is likely to upset pharma multinational companies, the Department of Pharmaceuticals of India has started the process of issuing compulsory licences for three commonly used anti-cancer drugs, Trastuzumab (Herceptin), Ixabepilone and Dasatinib.

Compulsory licensing (CL) by the government allows a domestic company to manufacture and sell a generic version of a patented drug with or without the consent of the patent-holder. Sections 84 and 92 of the Indian Patents Act, 1970, provide for CL in cases where the patented drug is unavailable, unaffordable, or if there are problems with its supply in India. CL reduces the price of a drug manifold, and is a practice in many developing countries.

The first drug to be issued a compulsory licence in India was Bayer’s Nexavar (sorafenib tosylate), a drug for liver cancer, last August. After the CL, Nexavar is available for Rs 8,880 per pack of 120 tablets (a month’s dose), over 95% cheaper than its pre-CL price.

Trastuzumab, Ixabepilone and Dasatinib are all more expensive that Nexavar, costing Rs 50,000, Rs 70,000-80,000 and Rs 15,000 respectively for a month’s dose.

Officials at the Department of Pharmaceuticals said it was too early to predict the post-CL price of these drugs. Dr Shyam Aggarwal, consultant oncologist at Sir Ganga Ram Hospital, said, “Even after the recent cut in the prices of Trastuzumab and Dasatinib, they are still way too expensive for the common man. 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.”

Editor’s note: This is a very recent news from India and although Roche has took some actions (check the links below) against this a couple of months before, the Indian Government will issue a CL for Herceptin. This new situation will also affect the biosimilars of Herceptin, their pricing strategies, the development decisions etc.

Source: The India Express

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