In a first for both the country and the company, the Drug Controller General of India approved Epirus Biopharmaceuticals Inc.' infliximab biosimilar.
Besides being the first biosimilar to Johnson & Johnson's Remicade approved in India, the Epirus drug, to be marketed as Infimab, is among the first drugs developed for the Indian market in accordance with the country's 2012 biosimilar guidance, which raised the bar for follow-on biologics. It also is the first approval anywhere for the Boston-based Epirus.
Infimab, formerly known as BOW015, will be manufactured by Epirus partner Reliance Life Sciences at its facility in Mumbai and will be commercialized in India by Ranbaxy Laboratories Ltd. The partners plan to launch the drug by the end of the year, Epirus CEO and President Amit Munshi told BioWorld Today.
In the meantime, they are working through distribution issues and laying out a pricing strategy that will ensure