NOVARTIS AG 
The
This means that
As US-approved biosimilars, Wyost and Jubbonti have the same dosage form, route of administration, dosing regime and presentation as the Xgeva® and Prolia®, which are are registered trademarks of
Medicines for Europe calls for simpler SPC manufacturing waiver
About the biosimilar medicines
Based on data from
Jubbonti
FDA shared that Jubbonti is approved for:
- osteoporosis in postmenopausal women who have a high risk of fracture
- to increase bone mass in men with osteoporosis at high risk for fracture
- to treat 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
Similarly, Wyost 120 mg/1.7 mL (70 mg/mL) injection is a human monoclonal antibody designed to bind to the RANKL protein.
FDA stated that Wyost is approved to:
- prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumours
- treat adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity
- treat hypercalcemia of malignancy refractory to bisphosphonate therapy.
The FDA noted that its decision for the biosimilars is based on clinical study data, which showed no clinically meaningful differences from the reference medicines. The approval is also accompanied by labelling with safety warnings.
The post
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