Pharmaceutical Executive March 5, 2024
The biosimilars Wyost and Jubbonti (denosumab-bddz) were approved as interchangeable products for Prolia and Xgeva for the treatment of osteoporosis, hypercalcemia, and to prevent skeletal-related events associated with bone metastases from solid tumors.
The FDA has approved a pair of interchangeable denosumab biosimilars developed by Sandoz and Samsung Bioepis—denosumab-bddz (Wyost) and denosumab-bddz (Jubbonti)—for use across all indications of the reference drug denosumab (Xgeva and Prolia), both manufactured by Amgen.1 The denosumab biosimilars have the same dosage, route of administration, regimen, and presentation as the approved reference products.
“Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease...
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