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Phase I Clinical Trial Results for Intas’ Denosumab Biosimilar Accepted by CDSCO

Aug 2, 2025

As reported by Medical Dialogues, India’s Central Drugs Control Organisation (CDSCO) has reviewed and accepted without objection a final Clinical Study Report (CSR) submitted by Intas Pharmaceuticals Ltd. for its proposed denosumab biosimilar.  In the CSR, data was presented from a randomised Phase I trial for Intas’ 120 mg / 1.7 mg denosumab injection.