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.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.