The Hindu Business Line : Dr Reddy’s to scale up biologicals operation

Mumbai, Feb 3 After a shaky opening with cancer-related biosimilar drug Filgrastim in 2001, Dr Reddy’s Laboratories (DRL) seems to have got it’s act together on biologic products. In fact, DRL is hoping to do a Grafeel (Filgrastim) with Reditux, the company’s second biosimilar product launched last year.

Grafeel is DRL’s brand of Filgrastim, whose aggressive pricing in the local market has, according to the company, helped in making the medicine accessible to more cancer patients. DRL is set to build on the learnings from these two products, to expand its biologics portfolio, besides scaling up its manufacturing and research capabilities.

New facility

Work is set to commence in a couple of months on its third manufacturing plant in Andhra Pradesh, slated to be operationalised in 2010.

At an estimated project cost of about $30 million (about Rs 120 crore), the plant would have a capacity of 5,000 litres, said Dr Cartikeya Reddy, DRL’s Vice-President and Head of Biologics.

The company has already pumped in a similar amount in its two existing biologics facilities and research operations. The 275-member biologics team is knowledge-intensive, he pointed out, given the skill involved in making biosimilars. Bio-generics are products that are similar to innovative biological products.

With about eight products in the pipeline, DRL is committed to launching a biological product every year. But with the regulatory pathway becoming clear in Europe, the primary focus is the domestic market, he indicated. DRL is looking to take its Grafeel to Europe in 2010. But more regulatory clarity is awaited in the US market.

Pricing

Grafeel, when it was launched locally, was priced at Rs 2,500 for a 300 micro-gram vial, almost half the price of the innovator product marketed in India by Roche.

Currently, the innovator has matched the price of Filgrastim bio-similars in the market and as a result, volumes have increased 10-fold, increasing the affordability by cancer patients, the company pointed out.

Reditux to treat Non-Hodgkin’s Lymphoma, launched last year, was priced at 40 per cent of the innovator’s (Roche) price of about Rs 1 lakh, he said.

DRL’s Reditux is priced at about Rs 40,000 for a 500 mg injection. But, whether there is a price-cut underway is something that will emerge depending on further technological innovations by the company, among other factors, he said.

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