FDA Approves Immgolis and Immgolis Intri as First Biosimilars to Golimumab Reference Products for RA and UC

The FDA has approved Immgolis (golimumab-sldi; Bio-Thera Solutions) and Immgolis Intri (golimumab-sldi; Bio-Thera Solutions) as interchangeable biosimilar biological products to Simponi (subcutaneous golimumab; Janssen Biotech) and Simponi Aria (intravenous [IV] golimumab; Janssen Biotech), respectively. These approvals mark a significant milestone in the treatment landscape for patients with several chronic autoimmune conditions.^1,2

FDA approval clears interchangeable golimumab biosimilars for rheumatoid arthritis and ulcerative colitis, promising lower-cost TNF therapy. | Image credit: Janssen Biotech - stock.adobe.com

What Was Approved

Immgolis and Immgolis Intri are the first biosimilars to their respective golimumab reference products. Immgolis was approved for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) in combination with methotrexate and for adults with moderately to severely active ulcerative colitis (UC). Immgolis Intri was approved for the treatment of adults with moderate to severe active RA in combination with methotrexate.¹

Immgolis is administered as a subcutaneous injection in a single-dose prefilled syringe; Immgolis Intri is prepared from a single-dose vial and administered as an IV infusion. Both products were developed and manufactured by Bio-Thera Solutions, a commercial-stage biopharmaceutical company based in Guangzhou, China.¹

"Bio-Thera is proud to have developed the first approved biosimilar of golimumab in the United States of America,” Shengfeng Li, PhD, CEO of Bio-Thera, said in a news release. "We are excited to support Accord BioPharma's commercialization efforts to bring [Immgolis] and [Immgolis Intri] to patients in need of an affordable biosimilar of golimumab who are living with the chronic, debilitating autoimmune conditions associated with moderately to severely active RA or UC."¹

Mechanism of Action

Golimumab is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF-α), a key proinflammatory mediator. By binding to TNF-α, golimumab reduces levels of several downstream inflammatory markers, including C-reactive protein, IL-6, ICAM-1, matrix metalloproteinase-3, and VEGF.¹

Clinical Evidence Supporting Biosimilarity

The FDA's approval was based on a comprehensive analytical, nonclinical, and clinical data package. Extensive analytical characterization of Immgolis and Immgolis Intri was conducted across structural, physicochemical, and biological properties. A randomized, double-blind, single-dose, 3-arm, parallel phase 1 study (NCT05332730) compared the pharmacokinetics, safety, and immunogenicity of Immgolis with both US and EU reference golimumab formulations in healthy volunteers. Additionally, a multicenter, randomized, double-blind, parallel-arm phase 3 study (NCT05046431) compared Immgolis with the reference golimumab product for efficacy, safety, and immunogenicity in patients with active psoriatic arthritis.¹

The FDA stated that the totality of evidence demonstrated no meaningful clinical differences between the biosimilars and the reference products, including comparable exposure and immunogenicity results in a human pharmacokinetic similarity study.²

Safety and Interchangeability

The adverse event (AE) profile observed with Immgolis and Immgolis Intri is consistent with that of the reference golimumab products. The most commonly reported AEs, which occurred in fewer than 5% of patients, include upper respiratory tract infection, nasopharyngitis, and injection site reactions. Serious potential AEs include malignancies and serious infections that could require hospitalization. Notably, where permitted by state law, pharmacies may dispense Immgolis and Immgolis Intri in place of the reference golimumab products, as both biosimilars have been designated interchangeable by the FDA.^1,2

Important Limitations of Use

Clinicians and pharmacists should be aware of the current approved labeling limitations. Immgolis is not indicated for active psoriatic arthritis or active ankylosing spondylitis in adults, nor for pediatric patients weighing at least 15 kg with moderately to severely active UC. Similarly, Immgolis Intri is not indicated for active psoriatic arthritis, active ankylosing spondylitis, or active polyarticular juvenile idiopathic arthritis. These limitations stem from ongoing patent litigation between Janssen Biotech and Bio-Thera Solutions related to those specific indications.¹

Industry Context and Patient Access Implications

The approvals arrive as the golimumab market enters a new competitive era. Johnson & Johnson reported US sales of approximately $1.08 billion for its golimumab products in 2024, and the reference golimumab products had previously faced no approved biosimilar competition in the US. With Immgolis and Immgolis Intri offering comparable safety and efficacy at potentially lower costs, these approvals are expected to meaningfully expand access for patients with RA and UC, which are conditions associated with substantial disease burden and long-term treatment costs. Pharmacists are well-positioned to counsel patients and providers on the interchangeability of these products and support transitions where appropriate.^1,2

References

1. Bio-Thera Solutions' golimumab biosimilars receive FDA approval as first biosimilars to Simponi and Simponi Aria. News release. Bio-Thera Solutions. May 18, 2026. Accessed May 18, 2026. https://www.prnewswire.com/news-releases/bio-thera-solutions-golimumab-biosimilars-receive-fda-approval-as-first-biosimilars-to-simponi-and-simponi-aria-accord-biopharma-to-commercialize-immgolis-golimumab-sldi-and-immgolis-intri-golimumab-sldi-in-the-united-st-302774570.html

2. FDA approves first interchangeable biosimilars to Simponi and Simponi Aria (golimumab) to treat rheumatoid arthritis and ulcerative colitis. News release. FDA. Updated May 15, 2026. Accessed May 18, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-interchangeable-biosimilars-simponi-and-simponi-aria-golimumab-treat-rheumatoid