ARTICLE | Clinical News

Infimab infliximab regulatory update

September 22, 2014 7:00 AM UTC

The Drug Controller General of India (DCGI) approved manufacturing and marketing of autoimmune therapy Infimab infliximab from Epirus. Infimab is India's first approved biosimilar of Remicade from Johnson & Johnson (NYSE:JNJ, New Brunswick) and Merck & Co. Inc. (NYSE:MRK, Whitehouse Station, N.J.). The approval is Epirus' first anywhere. J&J and Merck market Remicade worldwide to treat inflammatory diseases, including rheumatoid arthritis (RA), Crohn's disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis.

In January, Epirus granted Ranbaxy Laboratories Ltd. (NSE:RANBAXY; BSE:500359, Gurgaon, India) commercialization rights to Infimab in India, undisclosed Southeast Asian and North Africa. Epirus and Ranbaxy expect to launch Infimab by 1Q15. Epirus plans to begin an additional Phase III trial of Infimab in Europe in early 2015. ...