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Infliximab 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.
Ranbaxy and Epirus signed a licensing agreement for Infliximab in January of 2014.
Under the terms of the agreement, Epirus will develop and supply Infliximab, and Ranbaxy will register and commercialize it in India as well as in other territories in Southeast Asia, North Africa, and other selected markets.
The DCGI has issued the final clearances. Epirus and its commercialization partner Ranbaxy Laboratories are expected to launch the drug, under the brand name Infimab, by the first quarter of 2015.
"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 Mr Amit Munshi, president and CEO, Epirus. "We also intend to leverage this clinical data package to support additional regulatory filings in targeted global markets."
The biosimilar will be manufactured by Reliance Life Sciences at a facility in Mumbai.
