Epirus Biopharmaceuticals Inc, based in the US, has received final approval from India's drug regulator to manufacture and sell its biosimilar of infliximab used for treating inflammatory diseases.
The company said it received the final marketing and manufacturing approvals for BOW015, a biosimilar to Remicade of Johnson & Johnson, from Drug Controller General of India.
"Epirus and its commercialisation partner Ranbaxy Laboratories Ltd expect to launch the drug, under the brand name Infimab, by the first quarter of 2015," the company said in a statement.
The medicine is used for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn's Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis.
Epirus President and CEO Amit Munshi said: "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."
Under the terms of the agreement, Epirus will develop and supply BOW015, and Ranbaxy will register and commercialise BOW015 in India as well as in other territories in Southeast Asia, North Africa, and selected other markets, Epirus said.
Ranbaxy and Epirus had signed a licensing agreement for BOW015 in January, 2014.
At that time, Sanjeev Dani, Executive Vice President & Head, Global Strategy, Ranbaxy, had said, "We will utilise our strong front-end capabilities in making this product available in India and other parts of the world.
