Prove efficacy of Itolizumab for subcutaneous route: CDSCO panel Tells Biocon Biologics

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.

Itolizumab binds to CD6 which modulates T-lymphocyte activation and proliferation. It is an efficacious immunomodulatory compound investigated for treating psoriasis. Currently, the full mechanisms of action are still unclear.

At the recent SEC meeting for Dermatology and Allergy held on 17th August 2023, the expert panel reviewed the proposal presented by Biocon Biologics 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.

After detailed deliberation, the committee recommended that the firm should conduct a clinical trial for a new route of administration i.e. subcutaneous route to prove that the efficacy of the product is similar to the already approved route of administration in the proposed indication.

Accordingly, the expert panel suggested that the firm should submit the clinical trial protocol to CDSCO for review by the committee

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