Immgolis
Golimumab biosimilar developed by Not stated in the Purple Book. Reference product Simponi (Simponi Aria intravenous in the United States).
Brands by market: Immgolis and Immgolis Intri (USA) · Commercial partner or holder: Accord BioPharma (US applicant)
FDAMay 2026approved
EMAnot listed
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Immgolis
US Food and Drug AdministrationApprovedBrand
Immgolis
Holder or applicant
Accord BioPharma Inc.
Pathway
351(k)
Approved
May 2026
Application or permission
761452
Licence type
351(k) interchangeable, designated May 2026
Presentations
50 mg/0.5 mL, 100 mg/mL SC; Immgolis Intri 50 mg/4 mL IV
Note
First golimumab biosimilar in the United States; interchangeable on licensure.
Source
S001, S016
EMA
European Union
Not listed by EMA.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- FDAMay 2026Approved by FDA
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)
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