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Samsung Bioepis Co., Ltd. — Portfolio Competitive Intelligence Brief

Samsung Bioepis Co., Ltd. pipeline: 3 marketed, 0 filed, 5 Phase 3, 1 Phase 2. Recent regulatory actions, upcoming PDUFA, patent timeline, top competitor overlap.

3 marketed 0 filed 5 Phase 3 1 Phase 2 11 Phase 1 Live · 30-min refresh

Portfolio leaders (marketed + Phase 3 / filed)

DrugGenericPhaseClassTargetAreaFirst approval
SB5 (Adalimumab Biosimilar) SB5 (Adalimumab Biosimilar) marketed TNF-α inhibitor (monoclonal antibody biosimilar) TNF-α (tumor necrosis factor-alpha) Immunology
SB5 SB5 marketed TNF-α inhibitor (monoclonal antibody); biosimilar TNF-α (tumor necrosis factor-alpha) Immunology; Rheumatology
Lucentis (ranibizumab) Lucentis (ranibizumab) marketed VEGF-A inhibitor (monoclonal antibody fragment) VEGF-A (Vascular Endothelial Growth Factor A) Ophthalmology
Herceptin (trastuzuamb) Herceptin (trastuzuamb) phase 3 HER2-targeted monoclonal antibody HER2 (human epidermal growth factor receptor 2) Oncology
SB8 SB8 phase 3 VEGF inhibitor (monoclonal antibody) / Bevacizumab biosimilar VEGF (Vascular Endothelial Growth Factor) Oncology
Soliris (eculizumab) Soliris (eculizumab) phase 3 Monoclonal antibody C5 Immunology
Prolia® (Denosumab) Prolia® (Denosumab) phase 3 Monoclonal antibody RANKL Osteoporosis, Bone-related disorders
SB27 SB27 phase 3 TNF-alpha inhibitor TNF-alpha Rheumatology

Therapeutic area mix

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this portfolio.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this portfolio.

Patent timeline (forward window)

No upcoming patent expiries for this portfolio.

Competitive overlap (companies sharing drug classes)

  1. Hoffmann-La Roche · 3 shared drug classes
  2. Pfizer · 2 shared drug classes
  3. Amgen · 2 shared drug classes
  4. Celltrion · 2 shared drug classes
  5. Centocor, Inc. · 2 shared drug classes
  6. Merck Sharp & Dohme LLC · 2 shared drug classes
  7. Alvotech Swiss AG · 2 shared drug classes
  8. Sandoz · 2 shared drug classes

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Cite this brief

Drug Landscape (2026). Samsung Bioepis Co., Ltd. — Portfolio Competitive Intelligence Brief. https://druglandscape.com/ci/company/samsung-bioepis-co-ltd. Accessed 2026-05-16.

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