Ranbaxy inks licensing pact with Swiss firm Epirus for biosimilar product

Ranbaxy Laboratories Limited has entered into a licensing agreement with Epirus Switzerland GmbH, a wholly-owned subsidiary of Boston-based Epirus Biopharmaceuticals Inc, for BOW015, a biosimilar version of Infliximab. The product will be introduced in India and other emerging markets. Currently, there is no biosimilar of Infliximab approved in India.
 
Under the terms of the agreement, Epirus will develop and supply the product, and upon regulatory approval Ranbaxy will market the same in India and other emerging markets. Sanjeev I Dani, Executive Vice President & Head, Global Strategy, Ranbaxy, said, “We are pleased to partner with Epirus for biosimilar Infliximab. We will utilise our strong front-end capabilities in making this product available in India and other parts of the world.”
 
Amit Munshi, President and CEO, Epirus, commented, “We are very pleased to work with Ranbaxy to register and commercialize this important medicine. Ranbaxy has the right focus and infrastructure in these markets to effectively bring this product to the market”.
 
BOW015 is a biosimilar version of Infliximab, a biologic therapy marketed under the name Remicade. Epirus recently completed a successful Phase 3 trial which met its predefined endpoint, demonstrating comparability of BOW015 to Remicade as measured by ACR20 response in severe rheumatoid arthritis (RA) patients. The study also showed no meaningful differences between BOW015 and Remicade with regard to safety or immunogenicity.