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Dr Reddy's bets on big biosimilar gains

Gunning for big fortunes from biosimilars, pharmaceutical major Dr Reddy's Laboratories is looking to take its products to global markets in two phases.

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Looking to sell products in global markets

HYDERABAD: Gunning for big fortunes from biosimilars, pharmaceutical major Dr Reddy's Laboratories is looking to take its products to global markets in two phases, Cartikeya C Reddy, vice-president of the company's biologics development centre, told DNA Money.

In the first phase, the drug maker will launch  see some of the products already present in India in Europe; the second phase - beginning 2009 - could see some 4-5 new products hitting the global shelves, Reddy, a former employee of Genentech, a highly respected biotech pioneering firm, said.

Dr Reddy's had said earlier it was developing eight biosimilar products. It would launch one product every year.

While Reddy refused to go into the specifics of these products, he said the company's focus is on oncology and auto-immune diseases. It was not looking at insulins, erythropoietins, and interferons on which it was working earlier, he added.

Reddy said the company is looking at further boosting the capacity of the biologics development centre, currently spread over 36,000 sq ft; work will also begin later this year on a new mammalian cell culture plant which will be completed by 2009-end for $30 million, he added.

"While projections are going to be fraught with risks and one should be prepared for the long haul. We see that biologics can even be half the size of the company by 2015-2017," Reddy said.

The "great expectations" may not be misplaced if one considers that half the new drugs in development are biological in nature across the world while biopharmaceuticals worth about $60 billion are expected to be off patent by 2010.

Not surprisingly, many generics makers see great commercial rewards in this market which is predicted to have at least 50% of all new approvals in the biotech space.

In fact, Dr Reddy's already has two such biosimilar products in the Indian market. The first, Grafeel, (generic filgrastim), is a human granulocyte colony stimulating factor (GCSF), a recombinant protein indicated for chemotherapy induced neutropenia and in bone marrow transplantation and was approved in 2001.

The second Reditux, a generic version of rituximab, a monoclonal antibody (MAb) used in the treatment of non-hodgkins lymphoma currently marketed by Roche across the world.

In all probability, GCSF will be the first international biosimilar product from Dr Reddy's with a launch in Europe some time later this year or early next year, he said. The patent on the product expired in Europe on the originator product Neupogen in 2006. However, the country-wise rollout would depend on the supplementary protection certification (SPC), adopted by each, Reddy said.

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