Samsung Bioepis Obodence Shows Comparable Efficacy Across 456-Patient Population

Obodence (project name SB16), Samsung Bioepis's osteoporosis treatment, has demonstrated therapeutic effects similar to those of the original drug across a variety of patient groups.

Samsung Bioepis announced on the 18th that it presented the results of a follow-up subgroup analysis from the Phase 3 clinical trial of Obodence at the international osteoporosis conference (WCO-IOF-ESCEO) held in Prague, Czech Republic from April 16 to 19.

Samsung Bioepis building exterior in Songdo, Incheon. Samsung Bioepis

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This study was based on global Phase 3 clinical data involving 456 postmenopausal women with osteoporosis, evaluating how patient characteristics such as age, body mass index (BMI), and history of vertebral fracture affect drug efficacy.

The analysis assessed the rate of change in bone mineral density in the lumbar spine, hip, and femoral neck at 12 months after administration. The results showed that, regardless of demographic or disease characteristics, Obodence demonstrated therapeutic effects comparable to those of the original drug.

The company explained that these findings reconfirm the biological equivalence observed in the Phase 3 trial across various patient populations.

Donghoon Shin, Executive Vice President of Samsung Bioepis, said, "Through these study results, we have once again demonstrated the consistent therapeutic effects of Obodence across a wide range of patient groups in real-world prescribing environments. Moving forward, we will continue to strengthen our research and development capabilities to further expand the prescription of high-quality biopharmaceuticals based on scientific evidence."

Obodence is a biosimilar of Prolia, developed by Samsung Bioepis. In Korea, it is co-marketed with Hanmi Pharmaceutical. The company is also expanding its supply in the United States and Europe.

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