Samsung Bioepis

Focus: Samsung Bioepis is a South Korean biotechnology company specializing in biosimilars and biologics across oncology, immunology, and ophthalmology. The company derives 98% of revenue from REMICADE (infliximab biosimilar), indicating heavy dependence on a single product.

Oncology Immunology Musculoskeletal Ophthalmology

Profile data last refreshed 18h ago · AI intelligence enriched 1w ago

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About Samsung Bioepis

AI assessmentNot Hiring

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Why Work Here

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 Part D

LOE Approaching

Flagship product generating 98% of company revenue; approaching loss of exclusivity creates critical revenue cliff.

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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.

Established biosimilar portfolio with 10 approved products spanning high-value therapeutic areas including oncology and immunology, providing exposure to biologics manufacturing and regulatory expertise.
Active clinical pipeline with 20 ongoing trials (6 Phase 3 programs) across oncology, rheumatology, and ophthalmology, offering career development in late-stage development and commercialization.
Part of Samsung conglomerate providing corporate stability and access to capital for R&D investment in next-generation biologics.

Watch Out For

Extreme revenue concentration (98% from single product) creates vulnerability to patent cliff risk and limits financial flexibility for acquisitions or pipeline expansion.
Currently zero active job openings despite established pipeline, suggesting minimal hiring momentum and limited near-term career entry points.

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

ONTRUZANT

HER2-positive breast cancer

$2M Part D

Peak

HER2 antagonist biosimilar at peak commercial stage with minimal revenue contribution.

RENFLEXIS

TNF-mediated inflammatory diseases

$263K Part D

Peak

Infliximab biosimilar variant in peak phase with negligible revenue impact.

HADLIMA

TNF-mediated inflammatory diseases

$14K Part D

Peak

Adalimumab biosimilar with minimal commercial traction.

PYZCHIVA

Psoriasis, inflammatory bowel disease

Growth

IL-12 antagonist biosimilar in growth phase; potential revenue driver if market penetration accelerates.

EPYSQLI

Paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome

Growth

Complement inhibitor biosimilar in growth phase supporting pipeline diversification.

BYOOVIZ

Neovascular age-related macular degeneration

Peak

VEGF inhibitor biosimilar in ophthalmology; supports therapeutic area expansion.

DENOSUMAB-DSSB

Postmenopausal osteoporosis

Growth

RANK ligand inhibitor biosimilar in growth phase addressing musculoskeletal indications.

ETICOVO

Rheumatoid arthritis

Peak

TNF receptor antagonist biosimilar at peak commercial stage.

OPUVIZ

Neovascular age-related macular degeneration

Growth

VEGF pathway inhibitor biosimilar in ophthalmology growth phase.

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

Clinical Trials (1)

NCT03100734Observational Study to Evaluate the Real-Life Effectiveness of Benepali Following Transition From Enbrel

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 (1)

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

Phase 1

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