Ranbaxy Laboratories today announced the signing of a global development & marketing agreement with Zenotech Laboratories for its first biosimilar product, G-CSF (filgrastim).According to an official release issued by the company to the BSE today, 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. The company 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.Malvinder Mohan Singh, CEO & MD, Ranbaxy, said: "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 arid manufacture of biosimilar products. This also strengthens our existing alliance with Zenotech for Oncology products given our strategic stake in it."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.
