RANBAXY, ZENOTECH TO LAUNCH BIOSIMILAR DRUG

Indian drugmakers Ranbaxy Laboratories and Zenotech Laboratories have signed a global agreement to market and develop a biosimilar product, G-CSF (filgrastim).

Biosimilars are generic versions of biotherapeutics made using recombinant DNA technology, according to the companies. No Indian biosimilar product has yet been launched in Europe due to the substantial investment involved and other barriers to entry.

G-CSF is used to decrease the chance of infection in cancer patients who receive therapy that lowers white blood cell counts. The worldwide market for neutropenia treatment exceeds $4 billion, according to the companies.

Ranbaxy has made a commitment to launch G-CSF in Europe, where regulations for biosimilars are in place.

"This agreement signals Ranbaxy's foray into biosimilars by pooling in Ranbaxy's significant regulatory and front-end infrastructure with Zenotech's expertise in the development and manufacture of biosimilar products," Malvinder Mohan Singh, CEO managing director of Ranbaxy, said.

The product will be manufactured at Zenotech's biologics facility in Hyderabad, India.