Aurobindo Pharma arm reports positive Phase 3 trial results for osteoporosis drug

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CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma, has announced positive results from a pivotal Phase 3 clinical study of its denosumab biosimilar, developed as an alternative to Prolia (denosumab) for treating postmenopausal osteoporosis.

The study, conducted across 40 sites in five European countries on 446 postmenopausal women, met all clinical endpoints, showing no clinically meaningful differences between the biosimilar and the reference product.

Dr Arpit Prajapati, Head of Clinical Sciences at CuraTeQ, said the trial evaluated the biosimilar’s efficacy in improving bone mineral density (BMD) and reducing fracture risk. The primary endpoint — percentage change in lumbar spine bone mineral density (LS-BMD) at Week 52 — achieved the pre-defined equivalence margin of (-1.45, +1.45). The co-primary endpoint, measuring the area under the effect curve (AUEC) of serum C-terminal telopeptide (sCTX) from Week 0 to Week 26, was within the regulatory range of (0.80, 1.25), satisfying criteria set by the US FDA and the European Medicines Agency (EMA).

Dr Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ, said the company plans to begin regulatory submissions for the denosumab biosimilar in the EU, US, and other key regulated markets starting January 2026. The company has already held consultations with the FDA and is engaging with other regulators to facilitate a smooth review process.

Shares of Aurobindo Pharma were trading at Rs 1,125.30 on Friday, down 0.32 percent. The stock has lost 26.36 percent over the past year and has traded between Rs 1,010 and Rs 1,559.90 in the same period.