DeepMed Research

Samsung Bioepis Co., Ltd.

🇰🇷South Korea

Country: 🇰🇷South Korea

Ownership: Subsidiary

Established: 2012-01-01

Employees: 501

Market Cap: -

Website: http://www.samsungbioepis.com

Clinical Trials

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: Drug: SB27
Drug: Keytruda

First Posted Date: 2024-04-04

Last Posted Date: 2025-05-01

Lead Sponsor: Samsung Bioepis Co., Ltd.

Target Recruit Count: 616

Registration Number: NCT06348199

Locations: 🇹🇷
SB Investigative Site, Sivas, Turkey

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: SB27
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

Interventions: Combination Product: SB11 PFS

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: Humira (Adalimumab)
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: Stelara® (Ustekinumab)
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

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

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Ustekinumab

First Posted Date: 2021-02-26

Last Posted Date: 2022-04-05

Lead Sponsor: Samsung Bioepis Co., Ltd.

Target Recruit Count: 201

Registration Number: NCT04772274

Locations: 🇫🇷
Biotrial Rennes, Rennes, France

A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis

Phase 3

Completed

Conditions: Postmenopausal Osteoporosis

Interventions: Drug: SB16 (Proposed Denosumab Biosimilar)
Drug: Prolia® (Denosumab)

First Posted Date: 2020-12-11

Last Posted Date: 2025-02-04

Lead Sponsor: Samsung Bioepis Co., Ltd.

Target Recruit Count: 457

Registration Number: NCT04664959

Locations: 🇵🇱
SB Investigative Site, Łódź, Poland

Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Denosumab

First Posted Date: 2020-11-09

Last Posted Date: 2022-11-28

Lead Sponsor: Samsung Bioepis Co., Ltd.

Target Recruit Count: 168

Registration Number: NCT04621318

Locations: 🇺🇸
Biotrial, Newark, New Jersey, United States
🇫🇷
Biotrial Rennes, Rennes, France

Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Adalimumab

First Posted Date: 2020-08-17

Last Posted Date: 2021-05-26

Lead Sponsor: Samsung Bioepis Co., Ltd.

Target Recruit Count: 188

Registration Number: NCT04514796

Locations: 🇩🇪
Parexel International GmbH, Early Phase Clinical Unit Berlin, Berlin, Germany

A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Phase 3

Completed

Conditions: Neovascular Age-related Macular Degeneration

Interventions: Drug: SB15 (Proposed aflibercept biosimilar)
Drug: Eylea (Aflibercept)

First Posted Date: 2020-06-29

Last Posted Date: 2024-02-05

Lead Sponsor: Samsung Bioepis Co., Ltd.

Target Recruit Count: 449

Registration Number: NCT04450329

Locations: 🇷🇺
SB Investigative Site, Saint Petersburg, Russian Federation

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