CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, announced that its denosumab biosimilar, BP16, has successfully met the primary endpoints in a comprehensive pharmacokinetic (PK) and pharmacodynamic (PD) study. This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia®, obtained from both the EU and US markets.
Dr. Arpitkumar Prajapati, Head of Clinical Sciences at CuraTeQ Biologics, stated, “The results from our study confirmed that BP16 exhibits a PK profile nearly identical to the reference products, achieving key bioequivalence parameters—maximum serum concentration and area under the curve—within the established bioequivalence range of 80 -125 percent. Additionally, BP16 demonstrated comparable pharmacodynamics, safety, and immunogenicity profiles to both EU and US versions of the reference product. The study, which included 204 subjects from Australia and New Zealand, successfully met all the predefined endpoints.”
Denosumab works by specifically targeting the RANK ligand (RANKL), a critical protein in the lifecycle of osteoclasts, the cells that break down bone. Denosumab's ability to inhibit RANKL makes it highly effective in treating conditions linked to bone loss, such as osteoporosis in postmenopausal women, bone metastases from cancers, and cancer treatment-related bone health issues.
“With the positive Phase 1 study results, we are optimistic about our ongoing Phase 3 study. This study is progressing across multiple sites in the EU, focusing on women with postmenopausal osteoporosis, and we anticipate its completion by May/June 2025," said Dr. Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ Biologics. "We aim to submit a Marketing Authorization application to CHMP/EMA in the third quarter of this fiscal year.”