On June 2, 2025, Sandoz announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are now available to patients in the United States. WYOST® and Jubbonti® are the first and only interchangeable FDA-approved denosumab biosimilars and are approved to treat all indications of the reference medicines, XGEVA® and Prolia®.
The FDA approved WYOST® and Jubbonti® on March 5, 2024. Denosumab is a monoclonal antibody used to treat conditions such as osteoporosis and cancer-related skeletal complications.
Other developments continue in the denosumab biosimilars space. New research shows that Samsung Bioepis Co., Ltd.’s FDA-approved SB16 biosimilar has demonstrated equivalence to Prolia® at the 12-month mark in women with postmenopausal osteoporosis. Key data points included the percent change from baseline in lumbar spine bone mineral density, pharmacokinetics, pharmacodynamics, immunogenicity, and safety profiles. The FDA approved SB16 (denosumab-dssb) in February 2025. As we previously covered, Amgen has a pending BPCIA suit against Samsung Bioepis related to SB16.
Stay tuned to Big Molecule Watch as we continue to cover developments in the biosimilars industry.