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India : LICENSING Agreement for Biosimilar Product signed by Ranbaxy and Epirus

Publish Date : 10-Jan-2014

Ranbaxy Laboratories Ltd. and Epirus Switzerland GmbH, a wholly-owned subsidiary of Boston-based Epirus Biopharmaceuticals, Inc., declared the signing of a licensing agreement for BOW015, a biosimilar version of Infliximab.

BOW015 is biosimilar version of Infliximab, a biologic therapy marketed under the name Remicade. Epirus newly finished a successful Phase 3 trial which met its predefined endpoint, representing comparability of BOW015 to Remicade as measured by ACR20 response in harsh rheumatoid arthritis (RA) patients. The study in addition demonstrated no meaningful differences between BOW015 and Remicade with regard to protection or immunogenicity.

The company said that the products would be introduced in India and other Emerging Markets. At present, there is no biosimilar of Infliximab approved in India.

Epirus under the terms of the agreement will develop and supply the product, and upon regulatory approval Ranbaxy will market the same in India and other emerging markets.

Ranbaxy Executive Vice President & Head, Global Strategy Sanjeev I Dani said, "We are pleased to partner with Epirus for biosimilar Infliximab. We will utilize our strong front-end capabilities in making this product available in India and other parts of the world."

Epirus President and CEO Amit Munshi said, "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.

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