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    Aurobindo Pharma’s arm CuraTeQ Biologics completes key study of denosumab biosimilar

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    By Bl Hyderabad Bureau

    Copyright thehindubusinessline

    Aurobindo Pharma’s arm CuraTeQ Biologics completes key study of denosumab biosimilar

    CuraTeQ Biologics Pvt Ltd, a wholly-owned subsidiary of Aurobindo Pharma, has successfully completed 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 study met all clinical endpoints, demonstrating no clinically meaningful differences between the biosimilar and the reference product, the Hyderabad-based company said in a release on Friday.

    “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,’‘ Arpit Prajapati, Head of Clinical Sciences, CuraTeQ said.

    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,’‘ the company said.

    Published on September 19, 2025

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