CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, announced the successful completion of a Phase 3 clinical study for its denosumab biosimilar. The study, involving 446 women with postmenopausal osteoporosis across multiple European sites, demonstrated comparable efficacy to Prolia. Regulatory submissions are planned for the EU and US, with filings expected from January 2026. This achievement marks a significant milestone in developing a viable alternative for osteoporosis treatment.
Phase 3 Clinical Trial Success
CuraTeQ Biologics Private Limited, a wholly-owned subsidiary of Aurobindo Pharma, has successfully completed a pivotal Phase 3 clinical study evaluating its denosumab biosimilar against Prolia (denosumab). This study focused on women with postmenopausal osteoporosis.
Study Details and Results
The clinical study included a cohort of 446 women with postmenopausal osteoporosis. The study was conducted entirely in Europe, across forty sites in five countries. This study met all primary and secondary endpoints, demonstrating no clinically meaningful differences between the biosimilar and the reference product.
The primary endpoint was the percentage change in Lumbar Spine Bone Mineral Density (LS-BMD) at Week 52. The study also assessed the area under the effect curve (AUEC) of serum C-terminal telopeptide (sCTX) from Week 0 to Week 26. Results found to be within acceptable range of (0.80, 1.25), satisfying regulatory criteria.
Regulatory Plans
CuraTeQ plans to submit regulatory filings for the denosumab biosimilar in the EU, US and other key regulated markets from January 2026. The company is consulting with the FDA and other regulatory authorities.
Source: BSE
