Prove efficacy of Itolizumab for subcutaneous route: CDSCO panel Tells Biocon Biologics
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Biocon Biologics conduct a clinical trial of Itolizumab for Injection 100mg/vial for a new route of administration, subcutaneous route to prove that the efficacy of the product is similar with the already approved intravenous route for the product treatment of moderate-to-severe chronic plaque psoriasis.
This came after the drug major Biocon Biologics presented their proposal for approval of a subcutaneous route of administration in addition to the approved intravenous route for the product Itolizumab for Injection 100mg/vial for the approved indication i.e., treatment of moderate to severe chronic plaque psoriasis.
Itolizumab is a 'first in class' humanized IgG1 monoclonal antibody developed by Biocon and the Center of Molecular Immunology (CIM), Havana. Itolizumab is Biocon’s second ‘lab to market’ novel biologic after Nimotuzumab and offers a ‘best-in-class’ biologic drug for acute psoriasis.
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