JUBBONTI (Sandoz Pty Ltd)
Product name
JUBBONTI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
170 (255 working days)
Active ingredients
Denosumab
Registration type
New biosimilar medicine
Indication
Prevention of skeletal related events in patients with multiple myeloma and in patients with bone metastases from solid tumours.
Treatment of giant cell tumour of bone in adults or skeletally mature adolescents that is recurrent, or unresectable, or resectable but associated with severe morbidity.
Treatment of hypercalcaemia of malignancy that is refractory to intravenous bisphosphonate.