First Herceptin biosimilar in India may come before the end of 2013

August 22, 2013 10:19 AM

Roche has decided no to pursue an Indian patent for its blockbuster monoclonal antibody drug, Herceptin in India. This decision might mean a loss of millions of dollars for the Swiss giant but that might translate into a windfall for Bangalore-based biotech company Biocon reports Rediff.

As you can also read from our previous report, Roche had said that it would not pursue a patent for Herceptin in the country, allowing Indian biosimilar manufacturers to produce cheaper versions of trastuzumab, which it sells under the Herceptin brand name. It did not even renew its patent licence, which was due in May.

Early this year, the Indian government had decided to issue compulsory licences to three patented cancer drugs in India — trastuzumab, ixabepilone and dasatinib, after India’s Natco Pharma was given a compulsory licence to manufacture the generic version of Bayer’s patented anti-cancer drug Nexavar last year.

Biocon, which has completed Phase-III trials for Herceptin biosimilar, is expected to shortly launch the drug in India. Chairman & managing director Kiran Mazumdar-Shaw said: “We have completed the Phase-III trials and are awaiting the result. We are sure the product will be launched this financial year.” However, she refused to disclose details of the product’s pricing.

In the case of Herceptin, what gives Biocon an edge over other Indian pharmaceutical giants is the drug’s complex nature. As a biological drug, Herceptin is a monoclonal antibody — an area most Indian companies do not have an expertise in. So, other Indian players are unlikely to launch a Herceptin copycat before Biocon’s version hits the market.

When Herceptin first became available in India in 2011, it was priced at around Rs 1 lakh per vial. Last year, Roche lowered it to Rs 92,000. Later, the price was further reduced to Rs 72,000, when Roche entered into a tie-up with Emcure Pharma to launch Trastuzumab under the Herclone brand.

India is a Rs 130-crore (Rs 1.3 billion) market for Herceptin. The launch of Biocon’s biosimilar version is expected to lower the treatment cost with the drug to about half.

Biocon had last week rolled out its first biologic drug, ALZUMAb, for the treatment of auto-immune disease psoriasis. In 2009, it had partnered with Mylan Inc to develop five complex biosimilar drugs in the cancer and pain segment. According to the agreement, biosimilar Trastuzumab is the first one to hit the Indian market.

Other biosimilars for which studies are going on under the JV are Peg-filgrastim (Neulasta by Roche), Bevacizumab (Avastin by Roche), Adalimumab (Humira by Abbott) and Eternacept (Enbrel by Pfizer). These drugs together have a $33-billion market globally.

Source: Rediff

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