India's Biocon promises Herceptin biosim launch by fiscal year-end

Roche ($RHHBY) could have Indian competition for Herceptin sooner than it thought. Now that the Swiss drugmaker has decided to forego a patent fight over the breast cancer drug in India, domestic drugmakers are rubbing their hands together in anticipation.

Bangalore-based Biocon says it's gearing up to launch its biosimilar version by the end of March. "We have completed the Phase-III trials and are awaiting the result," CEO Kiran Mazumdar-Shaw said (as quoted by Rediff). "We are sure the product will be launched this financial year."

Biocon's opening comes after a quick tussle over Roche's Herceptin patent. Soon after the government said it was considering a compulsory license on Herceptin, allowing biosimilars onto the market before its patent expired, the Kolkata Patent office simply revoked the drug's divisional patents. Roche said late last week that it would bow out of that fight, opening its drug up to biosimilar rivals.

Though India's pharma industry is adept at copying branded pills, few of its companies are equipped to produce biosimilars. But two other drugmakers besides Biocon--Dr. Reddy's Laboratories and Intas Pharmaceuticals--are said to be working up their own Herceptin biosims. According to India's Business Standard, the two companies are likely to start clinical trials soon.

Both companies have some experience with complex cancer treatments. As the Business Standard points out, Dr. Reddy's already sells a biosimilar version of Rituxan, Roche's blood cancer and rheumatoid arthritis drug, marketed as MabThera in India. Intas launched Mabtas, its MabThera biosim, in 2007. 

Roche isn't out of the Indian market, though. It's not defending its Herceptin claims, but it has a joint venture with Emcure Pharma, which manufactures Herceptin and MabThera versions for the local market. Roche has cut the prices on both drugs, with the most recent cut taking Herceptin's price down by 31% to $1,366 per month.

Whether Biocon's version will be priced at a discount isn't yet clear--Mazumdar-Shaw wouldn't quote a price--but given the current brouhaha over access to cancer drugs in India, we'd wager that it will. 

- read the Rediff piece
- get more from Business Standard

Special Reports: Herceptin - Top 10 Best-Selling Cancer Drugs | Top 11 Fastest-Growing Generics Companies | Rituxan - Top 20 Orphan Drugs by 2018

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