Samsung Bioepis

Focus: Samsung Bioepis is a South Korea-based biotechnology company specializing in biosimilars and biologics across oncology, immunology, musculoskeletal, ophthalmology, and neurology. The company markets multiple FDA-approved biosimilar products with a commercial footprint in the US market.

Oncology Immunology Musculoskeletal Ophthalmology

Profile data last refreshed Yesterday · 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

Rheumatoid Arthritis, Crohn's Disease, Ulcerative Colitis

$111M Part D

LOE Approaching

Flagship biosimilar generating 98% of company revenue but facing patent/exclusivity cliff that threatens financial stability.

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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.

Portfolio of 10 marketed biosimilar products across high-value therapeutic areas (oncology, ophthalmology, immunology) provides diverse career exposure
Active pipeline of 30 programs with 7 Phase 3 trials underway offers advancement opportunities in clinical development and regulatory affairs
Part of Samsung conglomerate provides corporate backing and potential synergies across life sciences and technology platforms

Watch Out For

Extreme revenue concentration (98% from REMICADE biosimilar) creates vulnerability as this TNF inhibitor faces approaching loss of exclusivity
Zero current job openings and limited publicly disclosed hiring activity signal potential organizational constraints or restructuring phase
Early-stage pipeline (7 Phase 1 programs, only 7 Phase 3) relative to marketed portfolio indicates potential productivity gap in advancing novel assets

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

Breast Cancer, Gastric Cancer

$2M Part D

Peak

HER2-targeted oncology biosimilar at peak sales but representing minimal revenue contribution relative to REMICADE exposure.

RENFLEXIS

Rheumatoid Arthritis, Crohn's Disease, Ulcerative Colitis

$263K Part D

Peak

Alternative TNF inhibitor biosimilar offering modest revenue diversification but with similar LOE exposure to REMICADE.

EPYSQLI

Paroxysmal Nocturnal Hemoglobinuria, Myasthenia Gravis, Neuromyelitis Optica Spectrum Disorder

Growth

Complement inhibitor biosimilar in high-value rare disease indications representing key growth engine for future revenue.

OSPOMYV

Osteoporosis, Postmenopausal Osteoporosis, Osteopenia

Growth

RANK ligand inhibitor addressing large osteoporosis market with growth potential to offset REMICADE cliff.

OPUVIZ

Diabetic Macular Edema, Neovascular Age-Related Macular Degeneration

Growth

VEGF inhibitor biosimilar in ophthalmology addressing large ophthalmic market with strong growth trajectory.

PYZCHIVA

Plaque Psoriasis, Crohn's Disease, Ulcerative Colitis

Growth

IL-12 antagonist biosimilar with multi-indication profile (dermatology, GI) offering diversified market opportunity.

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

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

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

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

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

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

Eculizumab

Healthy

Phase 1

Clinical Trials (1)

NCT03722329Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 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

SB5

Healthy

Phase 1

Clinical Trials (1)

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

Phase 1

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

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

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

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

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

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

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

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

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 (1)

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