Biocon receives marketing authorisation from DCGI for novel biologic Itolizumab
Biocon 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. This approval paves the way for the launch of Biocon’s Alzumab in India, later during 2013.
Alzumab is a differentiated biologic drug with a superior safety profile compared to other approved biologic therapies given its very 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.
Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon said, “We are excited to receive this marketing authorisation for Itolizumab from DCGI which will enable Biocon to introduce this novel, first in class biologic for the treatment of psoriasis patients in India. 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 (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.”
EP News Bureau – Mumbai
