Aurobindo Pharma’s Subsidiary Reports Positive Phase 3 Results for Osteoporosis Biosimilar

CuraTeQ Biologics, a wholly owned subsidiary of

harma, has announced successful results from a Phase 3 clinical trial of its denosumab biosimilar, a potential alternative to Prolia for treating postmenopausal osteoporosis. The study, conducted across 40 sites in five European countries with 446 participants, met all clinical endpoints, demonstrating equivalence to the reference drug. The trial confirmed the biosimilar’s efficacy in improving bone mineral density and reducing fracture risk, with the primary endpoint—percentage change in lumbar spine bone mineral density at Week 52—falling within the predefined equivalence margin of (-1.45, +1.45). The co-primary endpoint, measuring serum C-terminal telopeptide from Week 0 to Week 26, also met regulatory standards set by the US FDA and EMA. CuraTeQ plans to initiate regulatory submissions in the EU, US, and other key markets starting January 2026. Aurobindo Pharma’s stock, trading at ₹1,125.30 on Friday, saw a slight dip of 0.32%, with a 26.36% decline over the past year.