U.S. License Holder:
Sandoz Inc.
Date of License:
March-05-2024 (Interchangeable)
Last Update:
Dec-15-2024
FDA-Approved Indications
JUBBONTI (denosumab-bbdz) is a RANK ligand (RANKL) inhibitor indicated for treatment:
Of postmenopausal women with osteoporosis at high risk for fracture;
To increase bone mass in men with osteoporosis at high risk for fracture;
Of glucocorticoid-induced osteoporosis in men and women at high risk for fracture;
To increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer;
To increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
WYOST (denosumab-bbdz) is a RANK ligand (RANKL) inhibitor indicated for:
Prevention of skeletal-related events in patients with multiple myeloma and in pateients with bone metastases from solid tumors;
Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity;
Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Jubbonti® / Wyost® (Sandoz) (February-2024)
Biosimilars Approved In The E.U.
Jubbonti® / Wyost® (Sandoz) (May-2024)
U.S. Patent Litigations