Infimab is being introduced in the Indian market through a licensing partnership with EPIRUS Biopharmaceuticals, and it will be manufactured by Reliance Life Sciences at a facility in Mumbai.
Reliance previously said that its manufacturing facility was inspected and approved in July. In addition to its contract manufacturing services for mAbs and recombinant proteins, Reliance has its own portfolio of eight biosimilars. Biosimilars for Remicade were also the first approved mAb biosimilars in Europe.
The innovator reference product from Johnson & Johnson is currently marketed for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn’s Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis.
Ranbaxy says that a Phase III trial met its predefined endpoint and demonstrated the comparability of Infimab to the reference innovator, although a spokesman would not expand on whether Infimab will be launched in other, more regulated markets. The study also showed no meaningful differences between Infimab and Remicade with regard to safety or immunogenicity.
Rajeev Sibal, VP & Country Head-India Region, Ranbaxy, said,“The product has been developed as per global standards and delivers a similar clinical outcome to the innovator. It will be available in India at a very significant discount as compared to the innovator drug. More Indian patients will get the benefit of a world-class biologic treatment.”
Meanwhile, other developers in India are eyeing the biosimilar industry as well. Dr Reddy's has made a number of investments over the past five years to ramp up production and development of biosimilars.
The investment comes as India back in 2012 unveiled 'similar biologics' guidelines to help developers proceed.