Teriparatide Biosimilar Demonstrates Therapeutic Equivalence in Postmenopausal Women With Osteoporosis

Prof. Dr. Med Peyman Hadji

Credit: Linkedin

RGB-10, a teriparatide biosimilar, has demonstrated therapeutic equivalence to reference teriparatide in treating osteoporosis in postmenopausal women at very high risk of fracture.¹

“This retrospective study evaluates for the first time in a real-world setting the comparative efficacy of a teriparatide biosimilar with reference teriparatide in reducing measures of osteoporosis in a population of postmenopausal women with osteoporosis at very high fracture risk using multiple assessment methods,” first author Prof. Dr. Med Peyman Hadji, Frankfurt Centre for Bone Health and Endocrinology, and Philipps University of Marburg, Germany, and coauthors wrote.¹

Hadji and coauthors performed a retrospective analysis of 25 postmenopausal female patients treated for osteoporosis with RGB-10 for 24 months and a matched cohort of 25 patients treated with reference teriparatide. They compared outcomes at 12 and 24 months of bone mineral density (BMD) at the lumbar spine, femoral neck and total hip using dual-energy x-ray absorptiometry (DXA) and integral, trabecular and cortical volumetric and surface BMD using 3D-SHAPER® imaging, trabecular bone score (TBS), quantitative ultrasound (QUS) measurements, and high-resolution peripheral quantitative computed tomography (HRpQCT) imaging of the radius and tibia.

“Since the expiration of the patent for the original teriparatide in 2019, several biosimilar compounds have been developed some of which have been granted marketing authorization,” Hadji and coauthors noted.¹

The investigators did not find any significant differences between the treatment groups on any measured parameters at any timepoints. At all timepoints, both treatment groups experienced significant improvements in measured parameters from baseline, although these were not all statistically significant and statistical significance sometimes differed between treatment groups.

The investigators noted that the major limitations of the study are its nature as a retrospective analysis, its single center source, and its relatively small number of patients included.

“Real-world evidence of the clinical benefit of the RGB-10 biosimilar in high fracture risk osteoporosis patients provides clinicians and patients with a valuable therapeutic option in this vulnerable patient group,” Hadji and coauthors concluded.¹

Similar research was presented last month at the 2024 European Congress of Rheumatology (EULAR) in Vienna, Austria, demonstrating equivalence between denosumab, another monoclonal antibody therapy for treating osteoporosis in postmenopausal women, and a proposed biosimilar, SB16. The new findings showed pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence, as well as equivalent efficacy, safety, and immunogenicity, in a phase 3 trial (NCT04664959).²

“SB16 is a human monoclonal antibody to the receptor activator of nuclear factor κΒ ligand that has been developed as a proposed biosimilar to reference denosumab,” first author Professor Richard Eastell, MD, FRCP, FRCPI, FRCPEdin, FRCPath, FMedSci, Clinical Medicine, School of Medicine and Population Health, and Professor of Bone Metabolism, and, Director of the Mellanby Centre for Musculoskeletal Research, University of Sheffield, and coauthors wrote in their abstract.²

REFERENCES

1. Hadji, P, Kamali, L, Thomasius, F, et al. Real-world efficacy of a teriparatide biosimilar (RGB-10) compared with reference teriparatide on bone mineral density, trabecular bone score, and bone parameters assessed using quantitative ultrasound, 3D-SHAPER® and high-resolution peripheral computer tomography in postmenopausal women with osteoporosis and very high fracture risk. Osteoporos Int. Published online August 2, 2024. doi: 10.1007/s00198-024-07208-z
2. Eastell R, Langdahl B, Chung YS, Plebanki R, et al. A randomized, Double-Blind, Phase III Study to Compare SB16 (Proposed Denosumab Biosimilar) to Reference Denosumab in Patients with Postmenopausal Osteoporosis: 18-Month Results. Presented at: EULAR. Vienna, Austria. June 12 – 15, 2024.