May 15, 2026 — The FDA has approved Immgolis (golimumab-sldi) as an interchangeable biosimilar to Simponi (golimumab), and Immgolis Intri (golimumab-sldi) as an interchangeable biosimilar to Simponi Aria (golimumab). Immgolis and Immgolis Intri are the first approved biosimilars for Simponi and Simponi Aria, respectively. Immgolis is administered as a subcutaneous injection in a single-dose prefilled syringe; Immgolis Intri is administered as an intravenous infusion prepared from a single-dose vial.
Approved Indications
Immgolis is approved for the following therapeutic indications in adults (consistent with the current approved indications for Simponi):
In combination with methotrexate, for the treatment of moderately to severely active rheumatoid arthritis (RA);
For the treatment of moderately to severely active ulcerative colitis (UC).
Immgolis Intri is approved for the following therapeutic indication in adults (consistent with the current approved indication for Simponi Aria):
In combination with methotrexate, for the treatment of moderately to severely active rheumatoid arthritis (RA).
Mechanism of Action
Golimumab products are human monoclonal antibodies that bind to a protein called tumor necrosis factor alpha (TNFα). By binding to TNFα, golimumab products block its ability to trigger inflammation, thereby helping to improve the signs and symptoms of the diseases listed above.
Safety Information
The expected side effects and adverse events for Immgolis and Immgolis Intri are consistent with those observed for Simponi and Simponi Aria.
Similar to Simponi/Simponi Aria, the most common expected side effects (incidence >5%) for Immgolis/Immgolis Intri include: upper respiratory infections, nasopharyngitis, and injection site reactions.
Golimumab products may cause serious side effects, including serious infections and malignancies (cancer). Patients treated with golimumab products are at increased risk for serious infections that may lead to hospitalization or death. For more information about the risks associated with Immgolis and Immgolis Intri, please see the full prescribing information.
Disease Overview
Rheumatoid Arthritis (RA)
An autoimmune inflammatory disease in which the immune system mistakenly attacks healthy cells in the body, causing inflammation (painful swelling) in the affected areas. RA primarily attacks joints and can affect multiple joints simultaneously.
Ulcerative Colitis (UC)
An inflammatory bowel disease (IBD) that affects the large intestine (colon) and rectum. It causes inflammation and ulcers in the lining of the colon, leading to various symptoms. The exact cause of UC is unknown, but it is believed to be an autoimmune disease in which the immune system mistakenly attacks healthy cells in the colon. Other factors that may contribute to UC include genetics, environmental triggers, and infections.
