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Infliximab biosimilar — Competitive Intelligence Brief

Infliximab biosimilar (Infliximab biosimilar) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: TNF-α inhibitor (monoclonal antibody). Area: Immunology.

marketed TNF-α inhibitor (monoclonal antibody) TNF-α (tumor necrosis factor-alpha) Immunology Biologic Live · refreshed every 30 min

Target snapshot

Infliximab biosimilar (Infliximab biosimilar) — Hanyang University Seoul Hospital. Infliximab biosimilar is a monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), reducing inflammatory signaling.

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Infliximab biosimilar TARGET Infliximab biosimilar Hanyang University Seoul Hospital marketed TNF-α inhibitor (monoclonal antibody) TNF-α (tumor necrosis factor-alpha)
Infliximab (Remicade) Infliximab (Remicade) University of California, San Diego marketed TNF-α inhibitor (monoclonal antibody) TNF-α (Tumor Necrosis Factor-alpha)
Humira® (Adalimumab) Humira® (Adalimumab) Mylan Inc. marketed TNF-α inhibitor (monoclonal antibody) TNF-α (Tumor Necrosis Factor-alpha)
infliximab therapeutic drug monitoring infliximab therapeutic drug monitoring Imelda GI Clinical Research Center marketed TNF-α inhibitor (monoclonal antibody) TNF-α (tumor necrosis factor-alpha)
Smartject Device delivery of Golimumab Smartject Device delivery of Golimumab Merck Sharp & Dohme LLC marketed TNF-α inhibitor (monoclonal antibody) TNF-α (Tumor Necrosis Factor-alpha)
Start adalimumab in monotherapy Start adalimumab in monotherapy Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives marketed TNF-α inhibitor (monoclonal antibody) TNF-α (tumor necrosis factor-alpha)
Infliximab and immunosuppressives Infliximab and immunosuppressives Children's Hospital of Fudan University marketed TNF-α inhibitor (monoclonal antibody) + immunosuppressive agents TNF-α receptor (via infliximab); multiple targets depending on co-administered immunosuppressive

Recent regulatory actions (last 90 days)

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

Upcoming PDUFA dates (next 180 days)

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

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (TNF-α inhibitor (monoclonal antibody) class)

  1. Merck Sharp & Dohme LLC · 3 drugs in this class
  2. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · 2 drugs in this class
  3. Hanyang University Seoul Hospital · 2 drugs in this class
  4. Biocad · 1 drug in this class
  5. Children's Memorial Health Institute, Poland · 1 drug in this class
  6. Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · 1 drug in this class
  7. Centocor, Inc. · 1 drug in this class
  8. Hikma Pharmaceuticals LLC · 1 drug in this class
  9. Hospital de Manises · 1 drug in this class
  10. Celltrion · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Infliximab biosimilar — Competitive Intelligence Brief. https://druglandscape.com/ci/infliximab-biosimilar. Accessed 2026-05-16.

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