Epirus’ Remicade Biosimilar Approved in India

Boston-based Epirus Biopharmaceuticals has received final approval in India for its biosimilar of the autoimmune therapy Remicade, making it the first biosimilar of the product in that country.

The Drug Controller General of India (DCGI) approved the product BOW015, which will be marketed in India by Epirus’s commercialization partner Ranbaxy. The company expects to launch the drug under the brand name Infimab by the first quarter of next year, Epirus said.

Remicade (infliximab) is marketed by Johnson & Johnson and Merck to treat inflammatory diseases, including rheumatoid arthritis, Crohn's Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis.

Epirus CEO Amit Munshi said the company will deliver a high-quality product to patients who may not be able to afford current treatment options. “We also intend to leverage this clinical data package to support additional regulatory filings in targeted global markets,” he added.

Under the licensing agreement, Ranbaxy may commercialize BOW015 in Southeast Asia, North Africa and other select markets.

Last year, Epirus said a Phase III study comparing the biosimilar with Remicade demonstrated the two drugs to be similar in efficacy and safety for treating severe rheumatoid arthritis after 16 weeks. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.