Biosimilars are generic versions of biotherapeutics using recombinant DNA technology.

G-CSF is used to prevent infections from cancer chemotherapy-induced neutropenia (decrease in the number of a type of white-blood cells). The worldwide market for neutropenia treatment is in excess of $4 billion, while the global G-CSF market is about $1.6 billion.

"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 and managing director of Ranbaxy, said in a filing with the Bombay Stock Exchange (BSE).

The agreement also strengthens Ranbaxy's existing alliance with Zenotech for oncology products, in which the Indian pharma major already has a strategic stake, he added.

G-CSF is used for preventing infections from cancer chemotherapy-induced neutropenia (decrease in the number of a type of white-blood cells) - the worldwide market for the treatment, which is pegged at over $4 billion. The global G-CSF market is about $1 .6 billion, the company said.

So far, no Indian biosimilar product has been launched in the EU due to the substantial investments involved in clinical trials and the regulatory expertise required. Both these aspects pose significant barriers to entry.

Ranbaxy has taken a strategic decision to commit resources to introduce the G-CSF product for global marketing beginning with markets in the EU where regulations for biosimilars are in place.

Zenotech is a specialty generic injectables company with strong expertise in the area of biotechnology. The company's predominantly high-value injectables product portfolios serve niche therapy areas like oncology, anesthesiology, gynecology, and neurology. The company has research and development facilities in India and in the US. Its oncology and biologics manufacturing facilities are located near Hyderabad.