Bangalore-based Biocon today said that it has received marketing authorization from the Drugs Controller General of India (DCGI) for its novel biologic Itolizumab, anti CD6 molecule, for the treatment of chronic plaque Psoriasis.
This approval paves the way for the launch of Biocon's Alzumab in India, later during 2013. Alzumab is a differentiated biologic drug, which the company says has a superior safety profile compared to other approved biologic therapies given its very low opportunistic infection rates.
"Itolizumab, is a first in class therapy with a unique mechanism of action and an excellent safety profile as indicated during the 52 week Phase III multi-centric clinical study conducted in India," Biocon said in a statement.
It is the second novel biologic developed by Biocon in India after BioMab EGFR, an anti-cancer monoclonal antibody.
A novel biologic indicated for the treatment of moderate-to-severe psoriasis, Alzumab will be marketed by Biocon's immunotherapy division. Alzumab, will be manufactured and formulated as an infusion drug at Biocon's Biopharma manufacturing facility at Biocon Park, Bangalore.
Kiran Mazumdar-Shaw, Chairman & Managing Director, Biocon said, "This approval paves the way for us to extend clinical development for other indications like rheumatoid arthritis (RA), multiple sclerosis (MS) and vitiligo. We also intend to file a US IND shortly to enable us to embark on a global clinical development plan. This is a defining moment for Biocon as it reaches a significant milestone in its mission of delivering affordable innovation to patients worldwide."