Publicly-held biotechnology major Biocon announced on Tuesday that it has received marketing authorisation from the Drugs Controller General of India (DCGI) for its novel biologic Itolizumab, anti CD6 molecule, for the treatment of chronic plaque psoriasis.
Itolizumab is a first-in-class therapy and the second novel biologic developed by Biocon at Asia’s largest biotech hub in Bangalore.
This approval paves the way for the launch of Biocon’s Alzumab in the country later this year. Alzumab is a differentiated biologic drug with a better safety profile compared to other approved biologic therapies, given its low opportunistic infection rates. 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.
Commenting on this development, Kiran Mazumdar-Shaw, chairman and managing director of Biocon, said, “This is our second novel biologic that we have developed in India, BioMab EGFR, an anti-cancer monoclonal antibody, being the first. This approval paves the way for us to extend clinical development for other indications like rheumatoid arthritis, multiple sclerosis and vitiligo.”
She added that the company will file an IND (investigational new drug) in the US shortly “to embark on a global clinical development plan”. She termed the approval for Itolizumab “a defining moment for Biocon”.
Alzumab is expected to provide a safe and effective treatment option for psoriasis, a socially debilitating disease affecting two-three per cent of India’s population. The global psoriasis market size is estimated to cross $8 billion by 2016.
Biocon’s share price dropped 2.3 per cent on the National Stock Exchange to close at Rs 294.70 per share on Tuesday.