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Samsung Bioepis Co., Ltd.

Samsung Bioepis Co., Ltd. logo
🇰🇷South Korea
Ownership
Subsidiary
Established
2012-01-01
Employees
501
Market Cap
-
Website
http://www.samsungbioepis.com

Clinical Trials

78

Active:45
Completed:29

Trial Phases

4 Phases

Phase 1:48
Phase 2:3
Phase 3:13
+1 more phases

Drug Approvals

28

CANADA:14

Drug Approvals

HADLIMA

Approval Date
Oct 25, 2023
CANADA

HADLIMA PUSHTOUCH

Approval Date
Oct 25, 2023
CANADA

BYOOVIZ

Approval Date
Mar 1, 2023
CANADA

ONTRUZANT

Approval Date
Jul 20, 2022
CANADA

ONTRUZANT

Approval Date
Jul 20, 2022
CANADA

AYBINTIO

Approval Date
Jun 27, 2022
CANADA

AYBINTIO

Approval Date
Jun 27, 2022
CANADA

HADLIMA PUSHTOUCH

Approval Date
Feb 19, 2021
CANADA

RENFLEXIS

Approval Date
Mar 22, 2018
CANADA

BRENZYS

Approval Date
Sep 23, 2016
CANADA
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Clinical Trials

Distribution across different clinical trial phases (65 trials with phase data)• Click on a phase to view related trials

Phase 1
48 (73.8%)
Phase 3
13 (20.0%)
Phase 2
3 (4.6%)
Phase 4
1 (1.5%)

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

Phase 3
Recruiting
Conditions
Non-small Cell Lung Cancer Stage IV
Interventions
First Posted Date
2024-04-04
Last Posted Date
2025-09-10
Lead Sponsor
Samsung Bioepis Co., Ltd.
Target Recruit Count
616
Registration Number
NCT06348199
Locations

SB Investigative Site, Sivas, Turkey (Türkiye)

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

Phase 1
Recruiting
Conditions
Non-small Cell Lung Cancer Stage II
Non-small Cell Lung Cancer Stage IIIA
Interventions
Drug: EU sourced Keytruda
Drug: US sourced Keytruda
First Posted Date
2024-02-20
Last Posted Date
2024-12-02
Lead Sponsor
Samsung Bioepis Co., Ltd.
Target Recruit Count
135
Registration Number
NCT06268613
Locations
🇹🇷

SB Investigative Site, Istanbul, Turkey

A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO

Phase 2
Completed
Conditions
Macular Edema
Neovascular Age-related Macular Degeneration
Retinal Vein Occlusion
First Posted Date
2023-12-20
Last Posted Date
2024-12-30
Lead Sponsor
Samsung Bioepis Co., Ltd.
Target Recruit Count
34
Registration Number
NCT06176963
Locations
🇵🇱

SB Investigational Site, Olsztyn, Poland

Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Phase 4
Completed
Conditions
Plaque Psoriasis
Interventions
Drug: SB5 (Adalimumab Biosimilar)
First Posted Date
2022-08-22
Last Posted Date
2023-05-25
Lead Sponsor
Samsung Bioepis Co., Ltd.
Target Recruit Count
371
Registration Number
NCT05510063
Locations
🇵🇱

SB Investigative Site, Świdnik, Poland

A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis

Phase 3
Completed
Conditions
Psoriasis
Moderate to Severe Plaque Psoriasis
Interventions
Drug: SB17 (Proposed Ustekinumab Biosimilar)
First Posted Date
2021-07-19
Last Posted Date
2025-05-25
Lead Sponsor
Samsung Bioepis Co., Ltd.
Target Recruit Count
503
Registration Number
NCT04967508
Locations
🇺🇦

SB Investigative Site, Zaporizhzhia, Ukraine

🇪🇪

SB investigative site, Tallinn, Estonia

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