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
Authors' conclusion
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.
Study context
- Population
- Postmenopausal women with osteoporosis who had received two 60-mg doses of RGB-14-P or RD (day 1 and week 26) in a randomised phase 3 study
- Participants
- 188 women
- Comparison
- Continued RGB-14-P vs continued reference denosumab vs transition from RD to RGB-14-P
- RGB-14-Pn = 63
- RDn = 63reference
- RD to RGB-14-Pn = 62
Methodological detailsblinded, phase 3, re-randomised 1:1:1 at week 52 (transition phase)
- Blinded
- Phase 3
- Re-randomised 1:1:1 at week 52 (transition phase)
Primary result
As reported in the abstract
Lumbar spine, hip and femoral neck BMD · up to week 78
- Gains in bone mineral density (BMD) observed in the first 52 weeks further improved up to week 78 in all three groups, including patients who transitioned from RD to RGB-14-P
Further findings
New fragility fractures
- Incidences comparable
Serum pharmacodynamics (PD) markers (serum C-telopeptide of type I collagen and procollagen type I N-terminal propeptide)
- Changes from baseline maintained
Immunogenicity
- Transition did not induce a discernible immunological reaction
Original publication
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. Osteoporos Int. Published 24 March 2026. doi:10.
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