Drug Type Biosimilar, Monoclonal antibody |
Synonyms Golimumab Biosimilar (Alvotech hf), 戈利木单抗生物类似药(Alvotech hf), AVT-05 + [4] |
Target |
Action inhibitors |
Mechanism TNF-α inhibitors(Tumor necrosis factor α inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Japan (19 Sep 2025), |
Regulation- |








| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Ankylosing Spondylitis | European Union | 17 Nov 2025 | |
| Ankylosing Spondylitis | Iceland | 17 Nov 2025 | |
| Ankylosing Spondylitis | Liechtenstein | 17 Nov 2025 | |
| Ankylosing Spondylitis | Norway | 17 Nov 2025 | |
| Non-radiographic axial spondyloarthritis | European Union | 17 Nov 2025 | |
| Non-radiographic axial spondyloarthritis | Iceland | 17 Nov 2025 | |
| Non-radiographic axial spondyloarthritis | Liechtenstein | 17 Nov 2025 | |
| Non-radiographic axial spondyloarthritis | Norway | 17 Nov 2025 | |
| Polyarticular Juvenile Idiopathic Arthritis | European Union | 17 Nov 2025 | |
| Polyarticular Juvenile Idiopathic Arthritis | Iceland | 17 Nov 2025 | |
| Polyarticular Juvenile Idiopathic Arthritis | Liechtenstein | 17 Nov 2025 | |
| Polyarticular Juvenile Idiopathic Arthritis | Norway | 17 Nov 2025 | |
| Ulcerative colitis, active moderate | European Union | 17 Nov 2025 | |
| Ulcerative colitis, active moderate | Iceland | 17 Nov 2025 | |
| Ulcerative colitis, active moderate | Liechtenstein | 17 Nov 2025 | |
| Ulcerative colitis, active moderate | Norway | 17 Nov 2025 | |
| Ulcerative colitis, active severe | European Union | 17 Nov 2025 | |
| Ulcerative colitis, active severe | Iceland | 17 Nov 2025 | |
| Ulcerative colitis, active severe | Liechtenstein | 17 Nov 2025 | |
| Ulcerative colitis, active severe | Norway | 17 Nov 2025 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Immune System Diseases | Preclinical | Iceland | - |
Phase 3 | - | 336 | xmcsjtofyq(bjskvxbnvn) = The 90% confidence intervals for the geometric means ratio for the protein-adjusted primary PK parameters were entirely contained within the prespecified margins of 80.00% and 125.00% (AUC0-inf [AVT05/US-RP 94.35, 108.40; AVT05/EU-RP 98.46, 113.13; EU-RP/US-RP 89.36, 102.76]) yffahqimju (izvphxbohx ) View more | Positive | 10 Nov 2025 | ||
Phase 1 | - | 336 | (AVT05 50mg s.c.) | liusivcbho(wjrhtofzez) = qhzxxxlwfn hpbybrysyn (ygmbdxrvrm, 52) View more | - | 28 May 2025 | |
(EU Simponi 50mg s.c.) | liusivcbho(wjrhtofzez) = afeyvwvjvj hpbybrysyn (ygmbdxrvrm, 50) View more | ||||||
Phase 3 | 502 | fwkrbfzncj(mduynlktgz) = cogextvmxc avqjvobeum (xvnndiyrem ) View more | Positive | 10 Nov 2024 | |||
Reference Golimumab | fwkrbfzncj(mduynlktgz) = cfrnyutqrh avqjvobeum (xvnndiyrem ) View more | ||||||
NCT05632211 (Biospace) Manual | Not Applicable | - | pszwhzngao(sszajbfbnr) = met its primary endpoints pqwysxudum (modjzjxhrl ) View more | Positive | 29 Nov 2023 | ||






