Samsung Bioepis has once again demonstrated the consistent therapeutic effect of its osteoporosis treatment Obodence (SB16). The company announced Thursday that it presented follow-up Phase 3 clinical trial results for Obodence, a biosimilar of Prolia, at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO), held from the 16th to the 19th in Prague, Czech Republic. Prolia, an osteoporosis treatment developed by U.S.-based Amgen, generates approximately 144.6 billion won ($106 million) in annual sales in the Korean market.
The research was conducted as a subgroup analysis of Samsung Bioepis' global Phase 3 clinical trial of SB16. It focused on examining how demographic characteristics such as age and body mass index, as well as disease characteristics including vertebral fracture history, affected drug efficacy in 456 postmenopausal women with osteoporosis.
Specifically, the therapeutic effect was verified by analyzing changes in bone mineral density at the lumbar spine, hip, and femoral neck in the patient group 12 months after administration of either SB16 or the original drug Prolia. The results showed that SB16 and Prolia demonstrated consistent therapeutic effects even when demographic and disease characteristic variables were taken into account.
"These research results once again demonstrate the consistent therapeutic effect of Obodence across a diverse range of patient groups in real-world prescription environments," said Shin Dong-hoon, Executive Vice President and Head of the Clinical Medicine Division at Samsung Bioepis. "We will continue to strengthen our research and development capabilities to expand prescriptions of high-quality biopharmaceuticals based on scientific evidence."
Meanwhile, Samsung Bioepis launched Obodence in Korea in July last year and is co-marketing it with Hanmi Pharmaceutical. In the United States, the drug is supplied through private insurers' pharmacy benefit managers (PBMs) under private-label programs, while in Europe, the company is expanding its global market share through direct sales.
