Ranbaxy Announces Global Entry into Biosimilars with Zenotech; Targets EU Markets First
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.
Tweet-- Ranbaxy Laboratories Limited (RLL) announced today the signing of 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 (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.
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.
Commenting on the occasion, Malvinder Mohan Singh, CEO & Managing Director of Ranbaxy Laboratories Ltd, 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 and manufacture of biosimilar products. This also strengthens our existing alliance with Zenotech for Oncology products given our strategic stake in the company."
Dr. Jayaram Chigurupati, CEO, Zenotech Labs said, "My team and I, 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.
Notes to Editor
About Zenotech Laboratories
Zenotech Laboratories Limited is a specialty generic injectables company with strong expertise in the area of bio-technology. Zenotech's predominantly high value injectables product portfolios serve niche therapy areas like oncology, anesthesiology, gynecology, and neurology. Zenotech has research and development facilities in India and in the U.S. Its oncology and biologics manufacturing facilities are located near Hyderabad, India.
About Ranbaxy Laboratories
Ranbaxy Laboratories Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies", resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 9 countries.