On 1 October 2024, the prestigious journal Nature published an article describing a retrospective cohort study comparing the efficacy of Evenity® (romosozumab) and Prolia® (denosumab) in treating male osteoporosis over 12 months, focusing on bone mineral density (BMD) changes and serum bone metabolism markers. Both drugs are monoclonal antibodies manufactured by US biotechnology company Amgen. While denosumab inhibits RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand) in osteoclasts, reducing bone resorption and thereby increasing bone density, romosozumab inhibits sclerostin, a protein that naturally inhibits bone formation, thereby increasing bone formation and reducing bone resorption, making it a dual-action agent.
The retrospective cohort study showed that romosozumab led to a significantly greater increase in lumbar spine BMD, and a transient rise in bone formation markers, compared to denosumab. The study concluded that romosozumab shows superior efficacy compared to denosumab in treating male osteoporosis.
While we have recently reported on the approval of denosumab biosimilars in various jurisdictions (see here and here, for example), to date no biosimilars for romosozumab have been approved.