Samsung Bioepis Co., Ltd.

ACTIVE

76 Songdogyoyuk-ro, Yeonsu-gu, Incheon, South Koreawww.samsungbioepis.comSubsidiary501–1,000 employeesEstablished: 2012-01-01

Clinical Trials

48 active

Approvals

Total approvals

Agencies

Regulatory bodies

Founded

2012

Overview

Trial Phase Distribution

Phase

Trials

Phase 1

61.7%

Phase 3

16.1%

Phase 2

4.9%

Phase 4

1.2%

Trial Status Distribution

Active, not recruiting

58.0%

Completed

37.0%

Not yet recruiting

1.2%

Recruiting

2.5%

Terminated

1.2%

Clinical Trials

Trials sponsored by this organization (81)

A Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of SB35 (Proposed Ixekizumab Biosimilar) to Taltz in Healthy Participants

Phase 1

Not yet recruiting

interventional

Sep 2026174 participants

A Study to Evaluate the Usability of the SB11 PFS in Trial Participants With Wet AMD, Macular Oedema Secondary to RVO, or mCNV

Phase 2

Completed

interventional

Mar 202630 participants

A Trial to Investigate the Safety of E303 in Participants With Advanced Refractory Solid Tumors

Phase 1

Recruiting

interventional

Mar 2026149 participants

A Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity between SB27 (proposed pembrolizumab biosimilar) and Keytruda in Subjects with Metastatic Non-squamous Non-small Cell Lung Cancer (SB27-3004)

Recruiting

interventional

May 202446 participants

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

Active, not recruiting

interventional

Mar 2024555 participants

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

Active, not recruiting

interventional

Jan 2024163 participants

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

Phase 2

Completed

interventional

Nov 202334 participants

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

Phase 4

Completed

interventional

Aug 2022371 participants

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Approvals

Approvals by Agency

CANADA

Health Canada

Approvals

SFDA

Saudi Food and Drug Authority

Approvals

Recent Approvals

News

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