Drug Type Biosimilar, Monoclonal antibody |
Synonyms Ustekinumab Biosimilar (Samsung Bioepis Co., Ltd.), 乌司奴单抗生物类似药(Samsung Bioepis Co., Ltd.), SB-17 + [5] |
Target |
Action inhibitors |
Mechanism IL-12 inhibitors(Interleukin-12 inhibitors), IL-23 inhibitors(Interleukin-23 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date South Korea (11 Apr 2024), |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Arthritis, Psoriatic | European Union | 19 Apr 2024 | |
Arthritis, Psoriatic | Iceland | 19 Apr 2024 | |
Arthritis, Psoriatic | Liechtenstein | 19 Apr 2024 | |
Arthritis, Psoriatic | Norway | 19 Apr 2024 | |
Crohn's disease, active moderate | European Union | 19 Apr 2024 | |
Crohn's disease, active moderate | Iceland | 19 Apr 2024 | |
Crohn's disease, active moderate | Liechtenstein | 19 Apr 2024 | |
Crohn's disease, active moderate | Norway | 19 Apr 2024 | |
Crohn's disease, active severe | European Union | 19 Apr 2024 | |
Crohn's disease, active severe | Iceland | 19 Apr 2024 | |
Crohn's disease, active severe | Liechtenstein | 19 Apr 2024 | |
Crohn's disease, active severe | Norway | 19 Apr 2024 | |
Plaque psoriasis | European Union | 19 Apr 2024 | |
Plaque psoriasis | Iceland | 19 Apr 2024 | |
Plaque psoriasis | Liechtenstein | 19 Apr 2024 | |
Plaque psoriasis | Norway | 19 Apr 2024 | |
Ulcerative colitis, active moderate | European Union | 19 Apr 2024 | |
Ulcerative colitis, active moderate | Iceland | 19 Apr 2024 | |
Ulcerative colitis, active moderate | Liechtenstein | 19 Apr 2024 | |
Ulcerative colitis, active moderate | Norway | 19 Apr 2024 |
GlobeNewswire Manual | Phase 3 | - | ndqebqmpfx(xghpqrrpuw): Difference = -0.6 (95% CI, −3.780 - 2.579) Met | Positive | 11 Oct 2023 | ||