CuraTeQ Biologics Completes Successful Phase 3 Trial for Denosumab Biosimilar in Postmenopausal Osteoporosis
Key Insights
CuraTeQ Biologics (search), an Aurobindo Pharma subsidiary, successfully completed a pivotal Phase 3 clinical study of its denosumab biosimilar in 446 postmenopausal women with osteoporosis (search) across 40 European sites.
The study met all clinical endpoints, demonstrating no clinically meaningful differences between the biosimilar and reference product Prolia, with primary endpoint achieving pre-defined equivalence margins.
The company plans to submit regulatory filings for the denosumab biosimilar in the EU, US, and other key markets starting January 2026, following consultations with the FDA and other regulatory authorities.
CuraTeQ Biologics (search) Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, has announced the successful completion of a pivotal Phase 3 clinical study evaluating its denosumab biosimilar against Prolia (denosumab) in postmenopausal osteoporosis (search). The rigorous study, conducted across 40 sites in five European countries, enrolled 446 women with postmenopausal osteoporosis and met all clinical endpoints, demonstrating no clinically meaningful differences between the biosimilar and the reference product.
Clinical Trial Design and Endpoints
The clinical trial was specifically designed to evaluate the efficacy of the denosumab biosimilar in enhancing bone mineral density (BMD) and mitigating fracture risk in postmenopausal women, a population particularly susceptible to osteoporosis (search). Dr. Arpit Prajapati, Head of Clinical Sciences at CuraTeQ, explained that the study achieved its primary objectives with statistical precision.
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). 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 was found to be within the acceptable range of (0.80, 1.25), satisfying regulatory criteria for both the US FDA and the European Medicines Agency (EMA).
Regulatory Strategy and Timeline
Dr. Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ, outlined the company's regulatory pathway forward. "CuraTeQ plans to submit regulatory filings for the denosumab biosimilar in the EU, US and other key regulated markets from January 2026," she stated. The company's regulatory team has already consulted with the FDA and is actively engaging with other regulatory authorities to ensure a smooth filing and an efficient review process.
Clinical Significance
According to Dr. Prajapati, these findings suggest that CuraTeQ's denosumab biosimilar exhibits comparable efficacy to Prolia, highlighting its potential as a viable alternative for patients in need of osteoporosis (search) treatment. The successful completion of this European multi-center study represents a significant milestone in expanding treatment options for postmenopausal women with osteoporosis.
The comprehensive nature of the study, spanning five countries and involving 40 clinical sites, provides robust evidence for the biosimilar's therapeutic equivalence to the reference product. This achievement positions CuraTeQ to potentially offer a more accessible treatment option in the osteoporosis (search) market upon regulatory approval.