Organization (Industry)
Samsung Bioepis (South Korea)
ClinicalTrials.gov lists Samsung Bioepis (South Korea) as lead sponsor of 33 trials. It has 32 active development programs and 16 approved assets.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 4 registered with a 2026 start date. The dashed outline is the pace from the 4 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 1.6 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Samsung Bioepis (South Korea): 33 lead-sponsored trials and 1 legal-entity registration.
Disease areas (17)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Arthritis, Rheumatoid | 7 |
| Carcinoma, Non-Small-Cell Lung | 3 |
| Lung Neoplasms | 3 |
| Macular Degeneration | 3 |
| Breast Neoplasms | 2 |
Showing 5 of 17 disease areas.
Trials by start year as sponsor or collaborator (13)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2026 (partial year) | 4 |
| 2024 | 2 |
| 2023 | 1 |
| 2022 | 1 |
| 2021 | 3 |
| 2020 | 4 |
| 2019 | 2 |
| 2018 | 3 |
| 2017 | 3 |
| 2016 | 2 |
Showing 10 of 13 years.
Recruitment duration, a model prediction: 1 trial still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (32)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| SB27 | Lung Neoplasms | Phase 3 | 2 |
| SB27 | Carcinoma, Non-Small-Cell Lung | Phase 3 | 2 |
| PEMBROLIZUMAB | Lung Neoplasms | Phase 3 | 1 |
| PEMBROLIZUMAB | Carcinoma, Non-Small-Cell Lung | Phase 3 | 1 |
| SB16 (Proposed Denosumab Biosimilar) | Osteoporosis | Phase 3 | 1 |
Showing 5 of 32 active programs.
Approved assets (16)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| SB5 | 3 |
| ADALIMUMAB | 3 |
| ETANERCEPT | 4 |
| INFLIXIMAB | 2 |
| DENOSUMAB | 2 |
Showing 5 of 16 approved assets.
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 79% hit target (n=14) | 53% on time (n=15) |
Journals published in (18)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Annals of the rheumatic diseases | 4 |
| JAMA ophthalmology | 3 |
| Advances in therapy | 2 |
| Arthritis & rheumatology (Hoboken, N.J.) | 2 |
| European journal of cancer (Oxford, England : 1990) | 2 |
Showing 5 of 18 journals.
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 15 | 2 | 2025-10-14 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| VAI | 5 |
FDA recalls (1)
| Product | Classification | Initiated |
|---|---|---|
| HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS Co., Ltd, Incheon, Republic of Korea, NDC 78206-183-01. | Class II | 2025-10-10 |
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 1 | 2026-06-01 |
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Samsung Bioepis Co., Ltd. | Incheon, KR | FDA, Health Canada |
Latest dated events (58)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-09-07 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-09-02 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-06-01 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-03-30 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-03-23 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
Showing 5 of 58 events.
Biomarker capability evidence (38)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| ERBB2 | Trial collaborator | Named in trial inclusion criteria |
| ERBB2 | Trial sponsor | Named in trial inclusion criteria |
| F2 | Trial collaborator | Named in trial inclusion criteria |
| PGR | Trial sponsor | Named in trial inclusion criteria |
| ALB | Trial sponsor | Named in trial exclusion criteria |
Showing 5 of 38 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, climate targets, as filed, workforce and board diversity, as filed, organization relationships, clia clinical laboratory certificates, and biomarkers this organization publishes on.