RxBNSimponi
golimumab
1 reference · 1 interchangeable
Reference Product
Simponi
golimumab
351(a) Reference Product (Approval Date 24-Apr-2009)
ApplicantJanssen Biotech, Inc.
BLA125289
RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Simponi
golimumab
351(a) Reference Product (Approval Date 24-Apr-2009)
ApplicantJanssen Biotech, Inc.
BLA125289
·RouteSubcutaneous
Presentation
AutoinjectorPre-Filled Syringe
Interchangeable Biosimilars
Immgolis
golimumab-sldi
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 15-May-2026)
ApplicantAccord BioPharma Inc.
BLA761452
RouteSubcutaneous
Presentation
Pre-Filled Syringe
Immgolis
golimumab-sldi
351(k) Interchangeable Biosimilar (Interchangeable Approval Date 15-May-2026)
ApplicantAccord BioPharma Inc.
BLA761452
·RouteSubcutaneous
Presentation
Pre-Filled Syringe
Biosimilars (not interchangeable)
No non-interchangeable biosimilars in this group.