Phase 3 study comparing the efficacy and safety of proposed biosimilar RGB-14-P with denosumab in postmenopausal women with osteoporosis: results from the transition (switch) phase

Treatment responses to RGB-14-P or RD seen during the first 52 weeks of treatment further improved to week 78; transitioning from RD to RGB-14-P had no discernible impact on efficacy, PD, immunogenicity, or safety. The totality of the evidence on the proposed biosimilar RGB-14-P available to date demonstrated structural and functional similarity as well as PK, PD, and therapeutic equivalence to reference denosumab, which suggests that RGB-14-P can be considered for long-term treatment, as well as a continuation of denosumab treatment.