Shares of Aurobindo Pharma jumped 3.69% to ₹1,097.05 on Friday after its biologics arm, CuraTeQ Biologics, announced successful Phase 1 trial results for BP16 — a biosimilar version of denosumab (marketed as Prolia in the US and Europe). The stock traded in the range of ₹1,081 to ₹1,109.80 during early trade, with a market cap nearing ₹638 billion.
BP16 is a novel biosimilar targeting osteoporosis in postmenopausal women, as well as bone complications arising from cancer and its treatments. It functions by inhibiting the RANKL protein, which is responsible for bone degradation.
The Phase 1 study, conducted on 204 healthy volunteers in Australia and New Zealand, demonstrated that BP16 achieved key bioequivalence markers — including maximum serum concentration and area under the curve — all within the acceptable 80–125% range when compared to the original Prolia formulation. The safety, pharmacodynamics, and immunogenicity profiles were also comparable.
Arpitkumar Prajapati, Head of Clinical Sciences at CuraTeQ Biologics, confirmed the biosimilar matched reference drugs in both EU and US markets across all predefined endpoints. Dr Disha Dadke, Head of R&D, noted that the Phase 3 trial is progressing in the EU and is expected to conclude by May–June 2025.
The success of BP16’s trials could position Aurobindo Pharma as a strong player in the global osteoporosis treatment market and strengthen its biosimilars portfolio.
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