🇺🇸 Infliximab biosimilar in United States
11 US adverse-event reports
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 11
Most-reported reactions
- Off Label Use — 2 reports (18.18%)
- Abdominal Discomfort — 1 report (9.09%)
- Abdominal Pain — 1 report (9.09%)
- Abdominal Pain Upper — 1 report (9.09%)
- Adjustment Disorder With Depressed Mood — 1 report (9.09%)
- Adverse Drug Reaction — 1 report (9.09%)
- Adverse Event — 1 report (9.09%)
- Alopecia — 1 report (9.09%)
- Amnesia — 1 report (9.09%)
- Anaemia — 1 report (9.09%)
Infliximab biosimilar in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Infliximab biosimilar approved in United States?
Infliximab biosimilar does not currently have US marketing authorisation in our dataset.
Who is the marketing authorisation holder for Infliximab biosimilar in United States?
Hanyang University Seoul Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.