Ranbaxy Laboratories Ltd. (RLL), one of the Indian pharma majors, has signed a global development & marketing agreement with Zenotech Laboratories Ltd. for its first biosimilar product, G-CSF (filgrastim).

G-CSF is used to prevent infections from cancer chemotherapy-induced neutropenia. The worldwide market for neutropenia treatment is in excess of $4 billion, while the global G-CSF has a strength of $1.6 billion, a Ranbaxy press release said.

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.

"This agreement signals Ranbaxy's foray into biosimilars by pooling in its significant regulatory and front-end infrastructure with Zenotech's expertise in the development and manufacture of biosimilar products. This also strengthens our existing alliance with Zenotech for oncology products given our strategic stake in the company", said Malvinder Mohan Singh, CEO & managing director of Ranbaxy Laboratories Ltd.

On its part, CEO of Zenotech Labs Dr Jayaram Chigurupati said, "the members of the company are proud to associate with Ranbaxy for development of G-CSF for the European Union and eventually for the US market. G-CSF will lead the way for the development of other biosimilar molecules within the Zenotech portfolio. These products will be manufactured in Zenotech's US FDA/EU approvable biologics facility in Hyderabad".
Biosimilars are generic versions of biotherapeutics using recombinant DNA technology. 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.