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
MHRANot listed
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Immgolis
Immgolis is the first golimumab biosimilar approved in the United States, in May 2026, held by Accord and interchangeable from the start. It comes in both the injection form and, as Immgolis Intri, the infusion form that matches Simponi Aria. Accord has not named the developer.
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
Reference product in the Purple Book
Simponi
Marketing status (Purple Book)
Prescription, marketed
Presentations
50 mg/0.5 mL, 100 mg/mL SC; Immgolis Intri 50 mg/4 mL IV
Remarks
First golimumab biosimilar in the United States; interchangeable on licensure.
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA
European Union
Not listed by EMA.
MHRA
United Kingdom
Not listed by MHRA.
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
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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