On 19 September 2025, Aurobindo Pharma subsidiary, CuraTeQ Biologics, announced positive results from its Phase 3 trial of BP16, biosimilar to Amgen’s Prolia® (denosumab).
The study, which was conducted across 40 sites in five European countries on 446 postmenopausal women, evaluated the biosimilar’s efficacy in improving bone mineral density (BMD) and reducing fracture risk. The trial met all clinical endpoints, showing no clinically meaningful differences between the biosimilar and the reference product.
According to the announcement, CuraTeQ plans to begin regulatory submissions for BP16 in the EU, US, and other key regions from January 2026.
In April 2025, CuraTeQ reported successful Phase I results for BP16, which included 204 subjects from Australia and New Zealand, demonstrating comparable safety, pharmacodynamics and immunogenicity profiles to both the European and US versions of Prolia®.