CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has successfully completed a pivotal clinical study evaluating its denosumab biosimilar against Amgen’s Prolia in a cohort of 446 women with postmenopausal osteoporosis.

Conducted entirely in Europe across 40 sites in five countries, the study met all clinical endpoints, demonstrating no clinically meaningful differences between the biosimilar and the reference product.  

Dr. Arpit Prajapati, Head of Clinical Sciences at CuraTeQ said, "The clinical trial was designed to evaluate the efficacy of the denosumab biosimilar in enhancing bone mineral density (BMD) and mitigating fracture risk in postmenopausal women, a population that is particularly susceptible to osteoporosis.”

She explained the results, “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).

“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 treatment,” Dr. Prajapati added.

CuraTeQ plans to submit regulatory filings for the denosumab biosimilar in the EU, US, and other key regulated markets from January 2026.

Dr. Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ, confirmed that the company’s regulatory team has consulted with the FDA and is actively engaging with other regulatory authorities to ensure a smooth filing and an efficient review process.