Aurobindo subsidiary completes denosumab biosimilar phase 3 study

Aurobindo Pharma announced the successful completion of a Phase 3 clinical study for a denosumab biosimilar by its wholly owned subsidiary, CuraTeQ Biologics Private Limited. The study evaluated the biosimilar against Prolia (denosumab) in 446 postmenopausal women with osteoporosis across forty sites in five European countries. The study met all clinical endpoints, showing no clinically meaningful differences between the biosimilar and the reference product.

The trial's primary endpoint, the percentage change in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 52, met the pre-defined equivalence margin of (-1.45, +1.45). The co-primary endpoint, the area under the effect curve (AUEC) of serum C-terminal telopeptide (sCTX) from Week 0 to Week 26, was within the acceptable range of (0.80, 1.25), satisfying regulatory criteria for both the US FDA and the European Medicines Agency (EMA).

CuraTeQ plans to submit regulatory filings for the denosumab biosimilar in the EU, US, and other key regulated markets starting from January 2026. The company's regulatory team is engaging with authorities to ensure a smooth review process.