Drug Topics March 5, 2024
The agency approved denosumab-bddz under two brand names: Wyost and Jubbonti.
Denosumab-bbdz (Wyost/Jubbonti) has received FDA approval and is the first and only biosimilar to denosumab (Prolia/Xgeva) available in the United States.1,2 Like the reference products, denosumab-bbdz has been approved under 2 brand names, which have different indications.2
Denosumab-bbdz was developed by Samsung Bioepis; Sandoz will commercialize the therapy as part of a partnership implemented in September 2023.
Wyost received approval for the following indications:
- To prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors
- To treat adults and skeletally mature adolescents with giant cell tumors of bone that are unrescetable or where surgical rescection is likely to lead to...
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