Samsung Bioepis

Focus: Samsung Bioepis is a South Korean biosimilar and biologics company headquartered in Incheon, specializing in oncology, immunology, and ophthalmology therapeutics. The company operates as a focused player in the competitive biosimilar market with a diversified portfolio of approved monoclonal antibodies and biologics.

Oncology Immunology Musculoskeletal Ophthalmology

Profile data last refreshed 11h ago · AI intelligence enriched 1w ago

Open Jobs

About Samsung Bioepis

AI assessmentNot Hiring

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Generated by Claude from Samsung Bioepis's SEC filings, pipeline programs, hiring velocity, FDA actions, and WARN data. Inference, not editorial — verify before quoting.

Data completeness

2/9 — Limited

Company HealthStrong

Pipeline

Late-stage

11 Phase 3+

LOE Risk

Protected

No near-term cliffs

Hiring

0 open

Automated analysis based on publicly available data (FDA, SEC, ClinicalTrials.gov). May be incomplete or delayed. This score does not reflect insider knowledge and should not be used as the sole basis for investment or employment decisions.

Key Products

REMICADE

TNF-mediated inflammatory diseases

$111M

LOE Approaching

Flagship product representing 98% of company revenue; approaching loss of exclusivity creates urgent business model risk.

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Pipeline & Clinical Trials

Herceptin

Breast Neoplasms

N/A

Clinical Trials (1)

NCT02771795A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC

N/A

Benepali

Rheumatoid Arthritis

N/A

Eculizumab

Healthy

Phase 1

Clinical Trials (1)

NCT03722329Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects

Phase 1

SB5

Healthy

Phase 1

Clinical Trials (1)

NCT02144714Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects

Phase 1

SB8

Healthy

Phase 1

Clinical Trials (1)

NCT02453672Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects

Phase 1

SB26

Healthy Volunteers

Phase 1

Clinical Trials (1)

NCT03630627A Phase I Study of SB26 in Healthy Volunteers

Phase 1

Pen of SB5

Healthy

Phase 1

Clinical Trials (1)

NCT02326233Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects

Phase 1

SB4

Healthy

Phase 1

Clinical Trials (1)

NCT01865552Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects

Phase 1

SB3

Healthy

Phase 1

Clinical Trials (2)

NCT07789964A Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of SB35 (Proposed Ixekizumab Biosimilar) to Taltz in Healthy Participants

Phase 1

NCT02075073Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects

Etanercept

Healthy

Phase 1

Clinical Trials (1)

NCT03193203Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects

Phase 1

E303

Advanced Solid Tumors

Phase 1

Clinical Trials (1)

NCT07524348A Trial to Investigate the Safety of E303 in Participants With Advanced Refractory Solid Tumors

Phase 1

Denosumab

Healthy

Phase 1

Clinical Trials (1)

NCT04621318Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects

Phase 1

SB2

Healthy

Phase 1

Clinical Trials (1)

NCT01922336Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects

Phase 1

Adalimumab

Healthy

Phase 1

Clinical Trials (1)

NCT04514796Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects

Phase 1

Ustekinumab

Healthy

Phase 1

Clinical Trials (1)

NCT04772274A 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

SB27

Non-small Cell Lung Cancer Stage II

Phase 1

Clinical Trials (1)

NCT06268613A 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

Adalimumab PFS and Pen

Rheumatoid Arthritis

Phase 2

Clinical Trials (1)

NCT02565810An Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis

Phase 2

SB11 PFS

Neovascular Age-related Macular Degeneration

Phase 2

Clinical Trials (2)

NCT06176963A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO

Phase 2

NCT07550504A Study to Evaluate the Usability of the SB11 PFS in Trial Participants With Wet AMD, Macular Oedema Secondary to RVO, or mCNV

Etanercept

Rheumatoid Arthritis

Phase 2

Clinical Trials (1)

NCT03193957An Multicentre Clinical Study to Evaluate the Usability and Safety of the Autoinjector and Pre-filled Syringe of SB4 in Subjects With Rheumatoid Arthritis

Phase 2

SB27

Non-small Cell Lung Cancer Stage IV

Phase 3

Clinical Trials (1)

NCT06348199A 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

SB16

Postmenopausal Osteoporosis

Phase 3

Clinical Trials (1)

NCT04664959A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis

Phase 3

Bevacizumab

Lung Cancer

Phase 3

Clinical Trials (1)

NCT02754882A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer

Phase 3

Herceptin

HER2 Positive Early or Locally Advanced Breast Cancer

Phase 3

Clinical Trials (1)

NCT02149524A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer

Phase 3

Enbrel

Rheumatoid Arthritis

Phase 3

Clinical Trials (1)

NCT01895309A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Phase 3

SB15

Neovascular Age-related Macular Degeneration

Phase 3

Clinical Trials (2)

NCT04450329A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Phase 3

NCT07844343A 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

Stelara®

Psoriasis

Phase 3

Clinical Trials (1)

NCT04967508A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis

Phase 3

Remicade

Rheumatoid Arthritis

Phase 3

Clinical Trials (1)

NCT01936181A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Phase 3

SB12

Paroxysmal Nocturnal Hemoglobinuria

Phase 3

Clinical Trials (1)

NCT04058158A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria

Phase 3

Humira

Rheumatoid Arthritis

Phase 3

Clinical Trials (1)

NCT02167139A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Phase 3

SB11

Age-Related Macular Degeneration

Phase 3

Clinical Trials (1)

NCT03150589A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Phase 3

Ontruzant

Breast Cancer

Phase 4

Clinical Trials (1)

NCT05036005Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON)

Phase 4

Humira

Plaque Psoriasis

Phase 4

Clinical Trials (1)

NCT05510063Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Phase 4

Benepali

Rheumatoid Arthritis

Phase 4

Clinical Trials (1)

NCT03813771Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification

Phase 4

Samsung Bioepis

About Samsung Bioepis

Key Products

Products & Portfolio (9)

Key Products by Revenue

Other Products (6)

Pipeline & Clinical Trials

Open Jobs (0)