Aurobindo Pharma Ltd has announced that its wholly owned subsidiary, CuraTeQ Biologics Pvt Ltd, has successfully completed a pivotal Phase 3 clinical trial of its denosumab biosimilar, benchmarked against Prolia (denosumab), in 446 postmenopausal women with osteoporosis. Conducted across 40 sites in five European countries, the study achieved all primary and co-primary endpoints, showing no clinically meaningful differences between the biosimilar and the reference product.
Dr. Arpit Prajapati, Head of Clinical Sciences at CuraTeQ, said the trial confirmed the biosimilar’s efficacy in improving bone mineral density and reducing fracture risk, with the Lumbar Spine Bone Mineral Density (LS-BMD) at Week 52 meeting the predefined equivalence margin. The co-primary endpoint measuring the area under the effect curve (AUEC) of serum C-terminal telopeptide (sCTX) also fell within the accepted regulatory range, satisfying US FDA and EMA criteria.
Dr. Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ, added that the company plans to submit regulatory filings for its denosumab biosimilar in the EU, US and other key regulated markets from January 2026 and is actively engaging with global regulators to ensure a smooth and efficient approval process.