India's Ranbaxy Gets Brazilian Nod for Generic Epivir

Reuters Health, July 13

BOMBAY (Reuters Health) Jul 13 - India's Ranbaxy Laboratories Ltd has become the first pharmaceutical company to get Brazilian approval to sell a biologically equivalent generic form of the GlaxoSmithKline AIDS drug Epivir, a spokesman told Reuters on Friday.

"We expect to launch our generic form of lamivudine in Brazil by September, in time to bid for a government tender for the AIDS drug, which we value at $20 million," Paresh Chaudhry said by phone from Ranbaxy headquarters in Delhi. Chaudhry said the Brazilian ministry of health expects generic forms of lamivudine to be priced 40% below the GlaxoSmithKline rate, and wants to distribute 22 million doses of the drug to AIDS patients in Brazil.

"Our drug is the first generic version of lamivudine that complies with a new Brazilian rule stipulating all generic forms should be biologically equivalent to the original drug," Ranbaxy regional director Vinod Dhawan told Reuters. "If we win the tender, we will start supplies early in 2002, and also plan to sell in the open market, though that is much smaller."

Dhawan said he does not know how many other bidders there will be for the tender.

The approval was received by a Ranbaxy subsidiary, Ranbaxy SP Medicamentos, a joint venture in Brazil with local partners. Ranbaxy owns 55% of the operation.

Indian law allows only for the patenting of processes by which drugs are made, not the drugs themselves. That permits companies to copy drugs under patent in the West using processes that differ from the original. The approach means Indian drugmakers spend little on research, reducing the costs significantly. Also, their manpower and production costs are very low, allowing them to supply drugs more cheaply.

Ranbaxy is India's top drugmaker by sales, and along with Bombay-based Cipla Ltd is an exporter of low-cost generic AIDS drugs. Cipla shocked global drugmakers in February by offering an AIDS triple drug cocktail for less than a dollar a day to international charities.

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