17 completed, 2 recruiting, 1 terminated. 10 Phase 1, 10 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 10 | Completed 9, Recruiting 1 |
| Phase 3 | 10 | Completed 8, Recruiting 1, Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma AVT32-DRL_PB, Keytruda - Melanoma | Phase 1 | Recruiting | Alvotech Swiss AG | 120 | 2026-08-10 | 2026-08-24 |
| Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema AVT29 (proposed aflibercept HD biosimilar), Eylea HD (aflibercept HD) - Diabetic Macular Edema | Phase 3 | Recruiting | Alvotech Swiss AG | 256 | 2026-04-22 | 2026-04-30 |
| Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio AVT80, Geographical region 1 Entyvio, Geographical region 2 Entyvio - Healthy Male and Female Subjects | Phase 1 | Completed | Alvotech Swiss AG | 385 | 2025-02-11 | 2026-01-20 |
| Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio AVT16, Vedolizumab - Ulcerative Colitis | Phase 3 | Terminated | Alvotech Swiss AG | 301 | 2024-09-23 | 2025-12-26 |
| Pilot Study of AVT16 in Healthy Adult Subjects AVT16 - Healthy | Phase 1 | Completed | Alvotech Swiss AG | 18 | 2024-05-29 | 2025-03-11 |
| Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease Patients will receive 1 IVT injection of AVT06 PFS depending on their chorioretinal vascular disease schedule - Chorioretinal Vascular Disease | Phase 3 | Completed | Alvotech Swiss AG | 35 | 2024-02-28 | 2025-04-22 |
| AVT03 With Xgeva in Healthy Male Subjects AVT03, Denosumab - This is a Phase I Study Conducted in Healthy Volunteers | Phase 1 | Completed | Alvotech Swiss AG | 208 | 2023-07-21 | 2025-05-15 |
| Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX AVT05 (proposed biosimilar to golimumab), Simponi (Golimumab) - Rheumatoid Arthritis | Phase 3 | Completed | Alvotech Swiss AG | 502 | 2023-03-30 | 2024-10-02 |
| A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants AVT05, Simponi - Healthy Adult Subjects | Phase 1 | Completed | Alvotech Swiss AG | 336 | 2022-12-16 | 2025-05-28 |
| Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND AVT03, Denosumab - Osteoporosis, Postmenopausal | Phase 3 | Completed | Alvotech Swiss AG | 532 | 2022-08-23 | 2025-05-29 |
| AVT03 With Prolia in Healthy Male Subjects AVT03, Prolia - Healthy Male Subjects | Phase 1 | Completed | Alvotech Swiss AG | 209 | 2022-06-29 | 2024-05-29 |
| Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE) AVT06 (proposed aflibercept biosimilar), Eylea® (Aflibercept) - Neovascular (Wet) AMD | Phase 3 | Completed | Alvotech Swiss AG | 413 | 2022-06-28 | 2024-09-27 |
| Efficacy, Safety, and Immunogenicity of AVT04 With Moderate-to-Severe Chronic Plaque Psoriasis Stelara, AVT04 - Psoriasis | Phase 3 | Completed | Alvotech Swiss AG | 581 | 2021-06-03 | 2023-02-02 |
| Pharmacokinetics, Safety and Tolerability Study of AVT04 to EU Approved and US Licensed Stelara (Ustekinumab) Stelara PFS - Psoriasis | Phase 1 | Completed | Alvotech Swiss AG | 294 | 2021-05-25 | 2022-05-23 |
| Pharmacokinetic, Efficacy, Safety, and Immunogenicity of AVT02 With Moderate to Severe Chronic Plaque Psoriasis Adalimumab originator, Adalimumab biosimilar - Plaque Psoriasis | Phase 3 | Completed | Alvotech Swiss AG | 567 | 2020-06-30 | 2022-05-04 |
| Auto-injector Real Life Handling in Patients Adalimumab - RA | Phase 3 | Completed | Alvotech Swiss AG | 107 | 2019-11-04 | 2022-05-05 |
| PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI) Adalimumab - Phase 1 | Phase 1 | Completed | Alvotech Swiss AG | 207 | 2019-07-01 | 2022-05-04 |
| Pharmacokinetics, Safety and Tolerability Study of AVT02 to EU-approved and US-licensed Humira (Adalimumab) Adalimumab - Healthy Volunteers | Phase 1 | Completed | Alvotech Swiss AG | 390 | 2019-03-20 | 2022-05-04 |
| Efficacy, Safety, and Immunogenicity of AVT02 With Moderate-to-Severe Chronic Plaque Psoriasis Adalimumab - Plaque Psoriasis | Phase 3 | Completed | Alvotech Swiss AG | 413 | 2019-02-20 | 2020-07-28 |
| Comparative Safety, Tolerability, Pharmacokinetic Study of AVT02 (100MG/ML) and Humira (100MG/ML) in Healthy Volunteers Adalimumab 100 MG/ML [Humira], AVT02 100MG/ML - Healthy Volunteers | Phase 1 | Completed | Alvotech Swiss AG | 24 | 2018-05-21 | 2019-01-18 |
Psoriasis (2) · Arthritis, Rheumatoid (1) · Colitis, Ulcerative (1) · Macular Degeneration (1) · Melanoma (1) · Osteoporosis, Postmenopausal (1) · Retinal Degeneration (1)
Adalimumab (6) · Denosumab (3) · Ustekinumab (2) · golimumab (2) · adalimumab biosimilar HS016 (1) · aflibercept (1) · pembrolizumab (1) · vedolizumab (1)
Georgia (8) · New Zealand (7) · Poland (6) · Ukraine (6) · Australia (5) · Bulgaria (3) · South Africa (3) · Czechia (2) · Estonia (2) · Latvia (2) · Slovakia (2) · United Kingdom (2) · Argentina (1) · Croatia (1) · Hungary (1)
Felicitas Bullo (3) · Eveline Schurink (2) · Steven Feldman, MD, PhD (2) · Chris Wynne (1) · Christian Schwabe (1) · Hans-Juergen Agostini (1) · Nemanja Damjanov, Prof (1) · Paul Duijzings, MSc (1) · Richard Bucknall (1) · Steve Feldmann, MD, PhD (1)
PMID 34657274, PMID 35107050, PMID 36205514, PMID 37204631, PMID 37212315, PMID 37435850, PMID 40357744, PMID 40357869, PMID 40512025, PMID 40698538, PMID 41182658, PMID 41212475