Samsung Bioepis to Promote Bone Disease Treatment at Domestic Conference

On-site Communication with "Obodens" at the Korean Society for Bone and Mineral Research Conference

Samsung Bioepis headquarters view. Photo by Samsung Bioepis

Samsung Bioepis is participating in the Korean Society for Bone and Mineral Research International Conference (SSBH 2025), which is being held from May 29 to May 31 at Walkerhill in Gwangjin-gu, Seoul, to promote its bone disease treatment, Obodens (Prolia biosimilar, active ingredient: denosumab).

As a major sponsor of the event, Samsung Bioepis plans to raise awareness of biosimilars and communicate the safety and efficacy of its product, which has demonstrated equivalence to the original medicine, through a luncheon symposium and the presentation of academic data.

In particular, together with Hanmi Pharmaceutical, with whom Samsung Bioepis signed a co-promotion agreement for Obodens in March, the company will engage in on-site booth activities and interact with a wide range of domestic medical and industry professionals in the field of bone diseases.

The original medicine for Obodens, Prolia, was developed by Amgen in the United States as a treatment for osteoporosis and bone loss in patients with prostate cancer and breast cancer. Last year, its global sales reached approximately 6.5 trillion KRW (4.374 billion USD), and the domestic market size was 174.9 billion KRW.

From October 2020 to November 2022, Samsung Bioepis conducted a Phase 1 clinical trial with 168 healthy adult men, and from November 2020 to January 2023, a Phase 3 clinical trial with 457 postmenopausal osteoporosis patients, thereby establishing clinical equivalence between the Prolia biosimilar (project name SB16) and the original medicine.

Based on these research and development achievements, Samsung Bioepis obtained product approval for Obodens from the Ministry of Food and Drug Safety in April, following approvals in the United States and Europe in February. With this, the company expanded its domestic biosimilar product portfolio to a total of 10 products.

Meanwhile, at this conference, Samsung Bioepis will present a poster showcasing research results that confirm the quality equivalence between the original medicines supplied in Europe and the United States and Obodens, using state-of-the-art comparative analysis methods.

According to the study, the structural, physicochemical, and biological properties of Obodens were similar to those of the original medicine. This finding, as part of the totality of evidence for equivalence, along with the results of Phase 1 and Phase 3 clinical trials, supports the safety and efficacy of Obodens.

Lee Jaeil, Executive Director and Head of the Bioanalysis Group at Samsung Bioepis, who was responsible for analyzing the quality data of Obodens, stated, "Through this conference, we will further validate the efficacy and safety of our product, and we will strive to provide more opportunities for domestic bone disease patients to receive treatment at more reasonable prices in the future."