Aurobindo Pharma Limited announced on Friday that its wholly owned subsidiary, CuraTeQ Biologics, has successfully completed a pivotal Phase 3 clinical trial of its denosumab biosimilar against Prolia®.
The large-scale study, conducted across 40 sites in five European countries with 446 postmenopausal women suffering from osteoporosis, met all primary and co-primary endpoints.
According to the trial results, CuraTeQ’s denosumab biosimilar showed no clinically meaningful differences when compared with the reference product. The primary endpoint — the percentage change in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 52 — met the pre-defined equivalence margin. Additionally, the co-primary endpoint assessing the area under the effect curve (AUEC) of serum C-terminal telopeptide (sCTX) from Week 0 to Week 26 also met the regulatory criteria for both the US FDA and the European Medicines Agency (EMA).
CuraTeQ Biologics plans to initiate regulatory filings in the EU, US, and other regulated markets from January 2026, ensuring a global launch pathway. The company has already consulted with the US FDA and is in discussions with other regulators to streamline the review process.
This milestone strengthens Aurobindo’s position in the biosimilars space, adding to its pipeline in osteoporosis care and expanding its global biologics footprint.
