On 10 April 2025, Aurobindo subsidiary, CuraTeQ Biologics, reported its successful Phase I results for BP16, biosimilar to Amgen’s Prolia® (denosumab).
The Phase I study, which included 204 subjects from Australia and New Zealand, showed that BP16 demonstrated comparable safety, pharmacodynamics and immunogenicity profiles to both the European and US versions of Prolia®; successfully meeting all the predefined endpoints.
CuraTeq anticipates completion of its Phase 3 study in women with postmenopausal osteoporosis by May/June 2025.
To date, there have been three sponsors with denosumab biosimilars approved in Europe: Celltrion’s Stoboclo®/Ozenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024). The EMA has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).
There are four sponsors with denosumab biosimilars approved in the US: Fresenius Kabi’s Conexxence® and Bomyntra® (March 2025), Celltrion’s Stoboclo® and Osenvelt® (March 2025), Samsung Bioepis’ Ospomyv™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (March 2024). A number of denosumab biosimilar BLAs are currently under review by the FDA, including for: Alvotech/Dr Reddy’s (March 2025), Amneal/mAbxience (March 2025), Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), and Teva (October 2024). Accord/Intas have also submitted an aBLA for INTP23 (denosumab, date of submission unknown).