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Biosimilar Infliximab — Competitive Intelligence Brief

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

marketed TNF-α inhibitor (monoclonal antibody) TNF-α (tumor necrosis factor-alpha) Immunology / Rheumatology / Gastroenterology Small molecule Live · refreshed every 30 min

Target snapshot

Biosimilar Infliximab (Biosimilar Infliximab) — Hikma Pharmaceuticals LLC. Biosimilar infliximab 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
Biosimilar Infliximab TARGET Biosimilar Infliximab Hikma Pharmaceuticals LLC marketed TNF-α inhibitor (monoclonal antibody) TNF-α (tumor necrosis factor-alpha)
Adalimumab treatment arm Adalimumab treatment arm Medical University of Vienna 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)
Golimumab (GLM) Golimumab (GLM) University College Dublin marketed TNF-α inhibitor (monoclonal antibody) TNF-α (Tumor Necrosis Factor-alpha)
Adalimumab Ab Adalimumab Ab Qilu Hospital of Shandong University marketed TNF-α inhibitor (monoclonal antibody) TNF-α (Tumor Necrosis Factor-alpha)
Adalimumab and its biosimilars Adalimumab and its biosimilars Hanyang University Seoul Hospital 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)

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

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