The Drug Controller General of India (DCGI) has approved marketing and manufacturing of Remicade (infliximab) biosimilar BOW015 of EPIRUS Biopharmaceuticals, Inc., a Boston-based biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies. BOW015 is the first infliximab biosimilar approved in India.
Ranbaxy Laboratories and EPIRUS Switzerland GmbH, a wholly owned subsidiary of Boston-based Epirus Biopharmaceuticals, Inc., have signed a licensing agreement for BOWO15, a biosimilar version of infliximab during January 2014. Under the terms of the agreement, EPIRUS will develop and supply BOW015, and Ranbaxy will register and commercialize BOW015 in India as well as in other territories in Southeast Asia, North Africa, and selected other markets.
"With these final clearances, we are now able to deliver a high quality product to patients who may not be able to afford current treatment options," said Amit Munshi, president and CEO of EPIRUS. "We also intend to leverage this clinical data package to support additional regulatory filings in targeted global markets."
BOW015 is a biosimilar to Remicade, which is marketed globally for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn's disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis. BOW015 will be manufactured by Reliance Life Sciences at a facility in Mumbai which was inspected and approved in July of this year. The DCGI has issued the final clearances for BOW015, and EPIRUS and its commercialization partner Ranbaxy Laboratories expect to launch the drug, under the brand name Infimab, by the first quarter of 2015.
"We believe that the data supporting BOW015's clinical comparability to Remicade, presented earlier this year at the EULAR meeting in Paris, combined with EPIRUS' focus on emerging markets, will help expand patient access to this important medicine," added Jonathan Kay, M.D., professor of medicine and director of clinical research in the division of rheumatology at UMass Memorial Medical Center and the University of Massachusetts Medical School. Dr. Kay serves as a clinical advisor to EPIRUS.