Biocon gets DCGI approval to market anti-psoriasis drug
New Delhi: Biotechnology major Biocon on Tuesday said it has received approval from drug controller DCGI to market its product 'Itolizumab', used in the treatment of psoriasis.
"The company has received market authorisation from the Drug Controller General of India (DCGI) for its novel biologic Itolizumab, anti CD6 molecule, for the treatment of chronic plaque psoriasis," Biocon said in a statement.
This approval paves way for the launch of the drug later in 2013 in India, it added.
Biocon CMD Kiran Mazumdar Shaw said: "We are very 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."
She added that the approval paves the way for the company to extend clinical development for other indications like Rheumatoid Arthritis (RA), Multiple Sclerosis (MS) and Vitiligo.
"We also intend to file a US IND (Investigational New Drug) shortly to enable us to embark on a global clinical development plan," Shaw added.
The global Psoriasis market size is estimated to cross USD 8 billion by 2016.
A novel biologic indicated for the treatment of Moderate- to-Severe Psoriasis, AlzumabTM will be marketed by Biocon's immunotherapy division, the company said.
The product would be manufactured and formulated as an infusion drug at Biocon's biopharma manufacturing facility at Biocon Park, Bangalore, it added.
Biocon scrip was trading at Rs 295.90 on the BSE in late afternoon trade, down 1.94 per cent from its previous close.