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Our Bureau

To enter global biosimilars market

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Hyderabad Feb. 7 Zenotech Laboratories Ltd (ZLL) on Wednesday announced an agreement with Ranbaxy Laboratories Ltd for the development and marketing of its first biosimilar product G-CSF (Filgrastim).

The agreement, which in this case would be exclusive for European market, would involve upfront licensing fees and profit sharing after launch, said Dr Jayaram Chigurupati, Chief Executive Officer (CEO) of the Hyderabad-based ZLL, while preferring not to disclose numbers.

To be put through regulatory rigour in Europe, the product, useful in preventing infections from cancer chemotheraphy-induced neutropenia or depletion of white-blood cells, would be the first biotech product developed in India and launched in EU, optimistically by 2010, he told newspersons.

The global market for neutropenia treatments is in excess of $4 billion, while the global G-CSF market is about $1.6 billion. ZLL, a four-year-old, research-driven start-up, with modest turnover of Rs 12.5 crore during fiscal 2005-06 has a robust pipeline of 10 products, some of which are in advanced stage, Dr Jayaram said.

Biosimilars are generic versions of biotherapeutics using recombinant DNA technology. High investments required in the entire chain of research, clinical trials and regulatory expertise, have been deterrents and no Indian company has launched a biosimilar product in EU, he said.

Ranbaxy has taken a strategic decision to commit resources to introduce G-CSF product for global marketing beginning with markets in EU, where regulations for biosimilars are in place. It would take two years for clinical trials, involving about 400 samples, Dr Jayaram explained.

The CEO and MD of Ranbaxy, Mr Malvinder Mohan Singh said the agreement signals Ranbaxy's entry into biosimilars. It also strengthens the existing alliance with Zenotech (in which it has a minority stake) for oncology products given the strategic stake in the company.

ZLL has already launched the product in India, in August 2006, after a clinical trial involving 100 patients. It has earned revenues in a few crores. For the emerging markets, it would be offered soon as well, he added.

Dr Jayaram said ZLL was in talks with big European companies for licensing agreements for its products, which are injectables in areas like oncology, gynaecology, neurology and anaesthesiology.

The Company has US Food and Drug Administration approved research and development facilities in India and US as well as its oncology and biologics manufacturing facilities, which give it a big advantage in the emerging biosimilars market, he said.

More Stories on : Alliances & Joint Ventures | Channels and Franchises | Pharmaceuticals | Ranbaxy Laboratories Ltd

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