Aurobindo Pharma's Subsidiary, CuraTeQ Biologics, Successfully Completes Phase 3 Clinical Study for Denosumab Biosimilar

CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, has successfully completed a pivotal clinical study evaluating its denosumab biosimilar against Prolia (denosumab) in a cohort of 446 women with postmenopausal osteoporosis. The study, conducted in Europe across forty sites in five countries, met all clinical endpoints, demonstrating no clinically meaningful differences between the biosimilar and the reference product. The primary endpoint, defined as the percentage change in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 52, successfully met the pre-defined equivalence margin of (-1.45, +1.45). The co-primary endpoint assessing the area under the effect curve (AUEC) of serum C-terminal telopeptide (SsCTX) from Week 0 to Week 26 was also found to be within the acceptable range. CuraTeQ plans to submit regulatory filings for the denosumab biosimilar in the EU, US and other key regulated markets from January 2026.