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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
Ranbaxy and Epirus announce the launch of India's first biosimilar for Remicade.
Through a licensing partnership with Epirus, Ranbaxy launched India’s first biosimilar treatment for Remicade (infliximab) on Dec. 1, 2014. Named Infimab, the medication is said to have equivalent clinical effectiveness in the treatment of rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, and psoriasis.
Although the approval of the biosimilar for Remicade is based on clinical trials in rheumatoid arthritis, it can be extrapolated to the aforementioned conditions. In India, if clinical similarity can be shown in a key indication, extrapolation of efficacy and safety data to other indication(s) of the reference product may be possible under certain conditions. Companies are responsible for providing justification for each of the claimed indications, however.
“[Infimab] has been developed as per global standards and delivers similar clinical outcome to the innovator,” noted Rajeev Sibal, vice-president and country head, India region at Ranbaxy, in a press release. “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.”
Epirus also has biosimilars for Humira (adalimumab) and Avastin (bevacizumab) in the works. Together, Humira, Remicade, and Avastin generated $26.2 billion in global sales in 2013, according to the release.
The announcement follows the news that Nippon Kayaku, in partnership with Celltrion, launched its own biosimilar to Remicade in Japan the day before, on Dec. 1, 2014. Nippon’s Infliximab BS is the first monoclonal antibody biosimilar to be approved in Japan and the second biosimilar developed by Nippon Kayaku.
Hospira’s biosimilar for Remicade, Inflectra, was the first monoclonal antibody to be approved in Europe; this version has been in use since 2013.