Drug Type Biosimilar, Monoclonal antibody |
Synonyms Denosumab biosimilar (Novartis), JUBBONTI + [1] |
Target |
Mechanism RANKL inhibitors(Tumor necrosis factor ligand superfamily member 11 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Drug Highest PhaseApproved |
First Approval Date US (05 Mar 2024), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Bone Cancer | EU | 17 May 2024 | |
Bone Cancer | IS | 17 May 2024 | |
Bone Cancer | NO | 17 May 2024 | |
Bone Cancer | LI | 17 May 2024 | |
Bone Diseases, Metabolic | LI | 16 May 2024 | |
Bone Diseases, Metabolic | IS | 16 May 2024 | |
Bone Diseases, Metabolic | NO | 16 May 2024 | |
Bone Diseases, Metabolic | EU | 16 May 2024 | |
Bone Diseases | US | 05 Mar 2024 | |
Bone metastases | US | 05 Mar 2024 | |
Giant Cell Tumor of Bone | US | 05 Mar 2024 | |
Glucocorticoid-induced osteoporosis | US | 05 Mar 2024 | |
Hypercalcemia | US | 05 Mar 2024 | |
Osteoporosis | US | 05 Mar 2024 | |
Osteoporosis, Postmenopausal | US | 05 Mar 2024 | |
Osteoporotic Fractures | US | 05 Mar 2024 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Fractures, Bone | NDA/BLA | US | 06 Feb 2023 | |
Humoral Hypercalcemia of Malignancy | NDA/BLA | US | 06 Feb 2023 | |
Osteoporosis, Postmenopausal | Preclinical | JP | 02 Jul 2019 | |
Osteoporosis, Postmenopausal | Preclinical | JP | 02 Jul 2019 |
Phase 3 | 527 | bpdqvvokpn(xnyutrmsay) = gwkdjugxme loykcdogvy (ahprdkzftv, pmlqcdvlza - bhcibtzzgk) View more | - | 08 Mar 2023 | |||
Phase 3 | - | (yfbwenqfmv) = ROSALIA study met primary endpoints, confirming proposed biosimilar denosumab matches reference product in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in postmenopausal women with osteoporosis pxtpcegalz (dseuvyvntq ) | Similar | 19 Sep 2022 | |||