CDSCO Panel Accepts Phase I Trial Data for Intas' Denosumab Biosimilar
New Delhi: The Subject Expert Committee (SEC) under the Analgesic and Rheumatology division of the Central Drugs Standard Control Organisation (CDSCO) has reviewed and accepted the final Clinical Study Report (CSR) submitted by Intas Pharmaceuticals Ltd. for its proposed biosimilar Denosumab 120 mg/1.7 ml injection, without raising any objections.
The development was discussed during the SEC meeting held on June 24, 2025, under file number E-54043. The CSR presented data from a Phase I, randomized, double-blind, three-arm, balanced, single-dose, parallel-group clinical trial, conducted under Protocol No. 0568-19. The study aimed to establish pharmacokinetic (PK) and pharmacodynamic (PD) comparability between Intas’ biosimilar Denosumab and the reference biologics Xgeva® from Amgen Inc., USA, and Amgen Europe B.V., The Netherlands.
The trial enrolled healthy adult male volunteers and evaluated bioequivalence and safety of the biosimilar candidate in a controlled setting, an essential step in the development of monoclonal antibody-based biosimilars.
Denosumab is a fully human monoclonal antibody targeting RANKL (Receptor Activator of Nuclear factor Kappa-Β Ligand), an essential regulator of osteoclasts, which are responsible for bone resorption. The reference product, Xgeva®, is widely approved for preventing skeletal-related events (SREs) in patients with bone metastases from solid tumors, as well as giant cell tumor of bone and hypercalcemia of malignancy.
Intas Pharmaceuticals Ltd., based in Ahmedabad, Gujarat, is a vertically integrated pharmaceutical company known for its strong biologics and biosimilars pipeline. The company has a wide global presence across North America, Europe, and Asia, and is committed to providing high-quality, affordable therapies in critical areas like oncology, rheumatology, and nephrology.
