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. This significant development was deliberated during the SEC meeting held on June 24, 2025, under file number E-54043. The CSR encompassed data derived from a Phase I, randomized, double-blind, three-arm, balanced, single-dose, parallel-group clinical trial, conducted under Protocol No. 0568-19. The primary objective of this study was to establish the 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, which involved healthy adult male volunteers, focused on evaluating the bioequivalence and safety of the biosimilar candidate in a controlled setting, marking a crucial step in the development of monoclonal antibody-based biosimilars. Denosumab, a fully human monoclonal antibody that targets RANKL (Receptor Activator of Nuclear factor Kappa-Β Ligand), plays a pivotal role in regulating osteoclasts responsible for bone resorption. The reference product, Xgeva®, is widely recognized for its efficacy in preventing skeletal-related events (SREs) in patients with bone metastases from solid tumors, giant cell tumors of bone, and hypercalcemia of malignancy. Intas Pharmaceuticals Ltd., headquartered in Ahmedabad, Gujarat, is a renowned vertically integrated pharmaceutical company with a robust portfolio of biologics and biosimilars. With a significant global presence spanning across North America, Europe, and Asia, the company is dedicated to delivering high-quality, cost-effective therapies in critical therapeutic areas such as oncology, rheumatology, and nephrology.
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