29 completed, 2 active not recruiting, 2 recruiting, 2 unknown. 15 Phase 1, 11 Phase 3, 5 Phase 2, 3 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 15 | Completed 12, Recruiting 2, Active not recruiting 1 |
| Phase 3 | 11 | Completed 10, Active not recruiting 1 |
| Phase 2 | 5 | Completed 5 |
| Phase 4 | 3 | Unknown 2, Completed 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 |
|---|---|---|---|---|---|---|
| A Trial to Evaluate the Safety and Usability of the SB15 PFS in Trial Participants With AMD, Macular Oedema Secondary to RVO, or Diabetic Macular Oedema SB15 PFS - Neovascular Age-related Macular Degeneration, Macular Oedema Secondary to RVO | Phase 2 | Completed | Samsung Bioepis Co., Ltd. | 33 | 2026-09-07 | 2026-10-15 |
| A Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of SB35 (Proposed Ixekizumab Biosimilar) to Taltz in Healthy Participants Ixekizumab - Healthy | Phase 1 | Recruiting | Samsung Bioepis Co., Ltd. | 174 | 2026-09-04 | 2026-10-14 |
| A Study to Evaluate the Usability of the SB11 PFS in Trial Participants With Wet AMD, Macular Oedema Secondary to RVO, or mCNV SB11 PFS - Age-Related Macular Degeneration, Branch Retinal Vein Occlusion With Macular Edema | Phase 2 | Completed | Samsung Bioepis Co., Ltd. | 30 | 2026-03-30 | 2026-04-24 |
| A Trial to Investigate the Safety of E303 in Participants With Advanced Refractory Solid Tumors E303 - Advanced Solid Tumors | Phase 1 | Recruiting | Samsung Bioepis Co., Ltd. | 149 | 2026-03-23 | 2026-10-01 |
| A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer SB27, Keytruda - Non-small Cell Lung Cancer Stage IV | Phase 3 | Active not recruiting | Samsung Bioepis Co., Ltd. | 555 | 2024-03-12 | 2026-07-07 |
| A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy SB27, EU sourced Keytruda, US sourced Keytruda - Non-small Cell Lung Cancer Stage II, Non-small Cell Lung Cancer Stage IIIA | Phase 1 | Active not recruiting | Samsung Bioepis Co., Ltd. | 163 | 2024-01-16 | 2026-05-05 |
| A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO SB11 PFS - Neovascular Age-related Macular Degeneration, Macular Edema | Phase 2 | Completed | Samsung Bioepis Co., Ltd. | 34 | 2023-11-21 | 2024-12-30 |
| Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis Humira (Adalimumab), SB5 (Adalimumab Biosimilar) - Plaque Psoriasis | Phase 4 | Completed | Samsung Bioepis Co., Ltd. | 371 | 2022-08-04 | 2023-05-25 |
| Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON) Ontruzant, Chemotherapy, Pertuzumab - Breast Cancer, Breast Neoplasms | Phase 4 | Unknown | Institut fuer Frauengesundheit | 108 | 2021-07-11 | 2023-04-18 |
| A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis Stelara® (Ustekinumab), SB17 (Proposed Ustekinumab Biosimilar) - Psoriasis, Moderate to Severe Plaque Psoriasis | Phase 3 | Completed | Samsung Bioepis Co., Ltd. | 503 | 2021-07-06 | 2025-05-25 |
| A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to European Union (EU) Sourced Stelara and United States of America (US) Sourced Stelara in Healthy Subjects Ustekinumab - Healthy | Phase 1 | Completed | Samsung Bioepis Co., Ltd. | 201 | 2021-02-04 | 2022-04-05 |
| A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis SB16 (Proposed Denosumab Biosimilar), Prolia® (Denosumab) - Postmenopausal Osteoporosis | Phase 3 | Completed | Samsung Bioepis Co., Ltd. | 457 | 2020-11-26 | 2025-02-04 |
| Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects Denosumab - Healthy | Phase 1 | Completed | Samsung Bioepis Co., Ltd. | 168 | 2020-10-19 | 2022-11-28 |
| Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects Adalimumab - Healthy | Phase 1 | Completed | Samsung Bioepis Co., Ltd. | 188 | 2020-08-13 | 2021-05-26 |
| A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD) SB15 (Proposed aflibercept biosimilar), Eylea (Aflibercept) - Neovascular Age-related Macular Degeneration | Phase 3 | Completed | Samsung Bioepis Co., Ltd. | 449 | 2020-06-23 | 2024-02-05 |
| A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria SB12 (proposed eculizumab biosimilar), Soliris (eculizumab) - Paroxysmal Nocturnal Hemoglobinuria | Phase 3 | Completed | Samsung Bioepis Co., Ltd. | 50 | 2019-08-07 | 2024-03-26 |
| Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification Benepali, Sulfasalazine, Methotrexate - Rheumatoid Arthritis | Phase 4 | Unknown | University of Leeds | 106 | 2019-03-01 | 2019-01-23 |
| Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects Eculizumab - Healthy | Phase 1 | Completed | Samsung Bioepis Co., Ltd. | 240 | 2018-11-13 | 2020-01-09 |
| A Phase I Study of SB26 in Healthy Volunteers SB26, Placebo - Healthy Volunteers | Phase 1 | Completed | Samsung Bioepis Co., Ltd. | 58 | 2018-08-22 | 2020-04-24 |
| A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD) SB11 (Proposed ranibizumab biosimilar), Lucentis (ranibizumab) - Age-Related Macular Degeneration | Phase 3 | Completed | Samsung Bioepis Co., Ltd. | 705 | 2018-03-14 | 2021-05-21 |
Showing 20 of 36. Sign in to see all of them.
Arthritis, Rheumatoid (7) · Carcinoma, Non-Small-Cell Lung (3) · Breast Neoplasms (2) · Macular Degeneration (2) · Psoriasis (2) · Axial Spondyloarthritis (1) · Hemoglobinuria, Paroxysmal (1) · Lung Neoplasms (1) · Macular Edema (1) · Neoplasms (1) · Osteoporosis, Postmenopausal (1) · Retinal Vein Occlusion (1)
Etanercept (5) · Adalimumab (3) · Ranibizumab (3) · Denosumab (2) · Trastuzumab (2) · Ustekinumab (2) · aflibercept (2) · eculizumab (2) · Bevacizumab (1) · Carboplatin (1) · Drug Therapy (1) · Hydroxychloroquine (1) · Infliximab (1) · Methotrexate (1) · Ontruzant (1)
Poland (14) · Germany (11) · South Korea (9) · Czechia (6) · United States (5) · Hungary (4) · Lithuania (4) · Romania (4) · Russia (4) · Spain (4) · Ukraine (4) · Bulgaria (3) · France (3) · India (3) · Thailand (3)
Hakim Charfi, MD (2) · Rainard Fuhr, M.D., Ph.D. (2) · Se Joon Woo (2) · Andreas Schneeweiss, MD, Prof. (1) · Asta Baranauskaite, M.D., Ph.D. (1) · David Han, M.D. (1) · Jiri Vencovsky, M.D., Ph.D. (1) · Jung-Yoon Choe, M.D., Ph.D. (1) · Martin Reck, M.D. (1) · Paul Emery, Professor (1) · Piotr Oleksy, M.D. (1) · Rainard Fuhr, MD (1) · Saumsung Bioepis (1)
PMID 31958281, PMID 32468892, PMID 33263165, PMID 26150601, PMID 26318384, PMID 26577771, PMID 27368117, PMID 28794078, PMID 28950421, PMID 28957563, PMID 28968793, PMID 29042358, PMID 29373094, PMID 29439289, PMID 29448072, PMID 30464411, PMID 30561229, PMID 31372961, PMID 31445454, PMID 32949267, PMID 33211076, PMID 35776269, PMID 36520462, PMID 37022687, PMID 37289448, PMID 37870163, PMID 38976126, PMID 39243386, PMID 39674388
2016 (2), 2014 (1), 2015 (1), 2025 (1)