CuraTeQ Biologics Pvt Ltd completes Phase 3 Clinical Study for Denosumab Biosimilar

CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd, is pleased to announce the successful completion of a pivotal clinical study evaluating its denosumab biosimilar against Prolia (denosumab) in a cohort of 446 women with postmenopausal osteoporosis. Conducted entirely in Europe across forty sites in five countries, this rigorous 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. 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. Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ commented, "CuraTeQ plans to submit regulatory filings for the denosumab biosimilar in the EU, US and other key regulated markets from January 2026. 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."

Shares of Aurobindo Pharma Limited was last trading in BSE at Rs. 1128.50 as compared to the previous close of Rs. 1096.25. The total number of shares traded during the day was 80979 in over 2562 trades.

The stock hit an intraday high of Rs. 1131.70 and intraday low of 1095.50. The net turnover during the day was Rs. 89941426.00.

Source : Equity Bulls

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AurobindoPharma INE406A01037 Pharmaceuticals CuraTeQBiologics Completion Phase3 ClinicalStudy DenosumabBiosimilar