Epirus Biopharmaceuticals, Inc., a Boston-based biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies, has received final marketing and manufacturing approvals for BOW015, a biosimilar version of Remicade (infliximab) biosimilar,  from the Drug Controller General of India (DCGI). BOW015 is the first infliximab biosimilar approved in India, according to Epirus.

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 Limited (Ranbaxy) expect to launch the drug, under the brand name Infimab by the first quarter of 2015.

Ranbaxy and Epirus signed a licensing agreement for BOW015 in January of 2014. Under 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.

Epirus is progressing applications for marketing approval for BOW015 in targeted global markets. The company also plans to initiate an additional Phase III trial in Europe in early 2015.

Source: Epirus