Samsung Bioepis Begins Phase 3 Clinical Trial for Osteoporosis Treatment Biosimilar

[Asia Economy Reporter Cho Hyun-ui] Samsung Bioepis announced on the 15th that it has commenced the global Phase 3 clinical trial of the biosimilar for osteoporosis treatment, 'SB16' (generic name Denosumab).

Last month, Samsung Bioepis began a Phase 3 clinical trial comparing the efficacy and safety of SB16 with the original drug in 432 postmenopausal osteoporosis patients across six countries.

SB16 is a biosimilar of 'Prolia,' a skeletal disease treatment developed by the US pharmaceutical company Amgen. It is used to treat bone loss in osteoporosis and cancer patients. Last year, its global sales amounted to approximately 3.1 trillion KRW (2.672 billion USD).

Since October this year, Samsung Bioepis has been conducting a Phase 1 clinical trial of SB16 on healthy volunteers, and by simultaneously conducting the Phase 3 trial on actual patients, it has been able to accelerate development.

A Samsung Bioepis official stated, "We will carry out the clinical trials of SB16 without any setbacks and successfully develop a biopharmaceutical that can benefit many patients."

This content was produced with the assistance of AI translation services.