Simponi and Simponi Aria Biosimilars Approved
On May 15, 2026, the US Food and Drug Administration (FDA) approved Immgolis™ (golimumab-sldi) and Immgolis Intri™ (golimumab-sldi) as the first interchangeable biosimilars to Simponi® (golimumab) and Simponi Aria® (golimumab), respectively. Immgolis is indicated for adult patients who have moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate and for adult patients who have moderately to severely active ulcerative colitis (UC). Immgolis Intri is indicated for adult patients who have moderately to severely active RA in combination with methotrexate. Accord BioPharma plans to make both available in the US market during the fourth quarter of 2026. Cost was not disclosed. Johnson & Johnson reported US sales of $1.2 billion for Simponi and Simponi Aria in 2025. For complete prescribing information, see here for Immgolis and here for Immgolis Intri.
At a Glance
- Brand Drug: Simponi® (golimumab); Simponi Aria® (golimumab)
- Biosimilar(s): Immgolis™ (golimumab-sldi); Immgolis Intri™ (golimumab-sldi)
- Manufacturer: Accord BioPharma and Bio-Thera Solutions
- Date Approved: May 15, 2026
- Interchangeability: Designated interchangeable; pharmacy-level substitution is subject to state law
- Indication: Immgolis: adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate; adult patients with moderately to severely active ulcerative colitis (UC). Immgolis Intri: adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate.
- Dosage Forms Available: Immgolis: 50mg/0.5mL and 100mg/mL single-dose prefilled syringes (SC). Immgolis Intri: 50mg/4mL (12.5mg/mL) single-dose vial (IV infusion).
- Launch Date: Q4 2026
- Annual US Sales: $1.2 billion in US sales in 2025.
- Estimated Annual Cost: Not yet announced.
- Immgolis and Immgolis Intri were designated interchangeable by the FDA, meaning they may be substituted at the pharmacy level, subject to applicable state pharmacy laws.
- Approval was supported by extensive analytical similarity assessments including structural and functional attributes, and by a human pharmacokinetic (PK) similarity study showing comparable exposure and immunogenicity overall.
- Both products carry a boxed warning for serious infections and the risk of cancer.
- The most common side effects include upper respiratory tract infection, increased liver enzymes, viral infection, decreased neutrophil count, bronchitis, hypertension, injection site reactions, nasopharyngitis, and rash.
- With this approval, Immgolis and Immgolis Intri (golimumab-sldi) become the 86th biosimilar, and the 21st unique reference product now has an approved biosimilar.