On 18 May 2026, the US Food and Drug Administration (FDA) approved Immgolis (golimumab-sldi) and Immgolis Intri (golimumab-sldi), marking the first interchangeable biosimilars to Janssen’s (Johnson & Johnson, J&J) anti-tumour necrosis factor (TNF) therapies Simponi and Simponi Aria.
Golimumab is a monoclonal antibody that neutralises TNF-alpha to treat inflammatory conditions such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [1].
Developed by Bio-Thera Solutions and commercialized in the US by Accord BioPharma, Imgolis (golimumab-sldi) is approved as a subcutaneous injection, while Immgolis Intri (golimumab-sldi) is an intravenous infusion. Importantly, both carry interchangeability designation, permitting pharmacy-level substitution where state laws allow. The approval opens the final major anti-TNF class in the US to biosimilar competition, following earlier market entries for adalimumab and infliximab.
The products are approved for the same indications as their respective reference products. Immgolis is indicated for adults with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate, active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), active non-radiographic axial spondyloarthritis (nr-axSpA), and moderately to severely active ulcerative colitis (UC). Immgolis Intri is indicated for RA in combination with methotrexate, active PsA, active AS, and active polyarticular juvenile idiopathic arthritis (pJIA).
The FDA based its decision on comprehensive analytical, pharmacokinetic, and clinical data demonstrating biosimilarity in efficacy, safety, and immunogenicity, alongside switching studies that specifically supported the interchangeability designation.
Accord BioPharma plans a commercial launch in the fourth quarter of 2026. The launch is expected to broaden treatment options for patients with chronic inflammatory diseases and may reduce healthcare expenditures through increased market competition.
This approval adds to Bio-Thera’s growing US portfolio, which already includes Avzivi (bevacizumab-tnjn) [2] and Tofidence (tocilizumab-bavi) [3], both approved in 2023, and Starjemza (ustekinumab-hmny), approved in 2025 [4].
Furthermore, Bio-Thera’s golimumab biosimilar, Gotenfia [5], was approved in Europe on 16 February 2026.
Beyond portfolio expansion, this milestone reinforces Bio-Thera’s ability to obtain marketing approvals across major regulated markets, while providing Accord BioPharma with a strategic foothold into another key immunology segment.
Industry watchers will monitor whether the interchangeable status accelerates clinical adoption relative to previous biosimilar launches in rheumatology and gastroenterology.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Clinical trials begin for Bio-Thera’s golimumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jun 22]. Available from: www.gabionline.net/biosimilars/research/clinical-trials-begin-for-bio-thera-s-golimumab-copy-biological
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves bevacizumab biosimilar Avzivi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jun 22]. Available from: www.gabionline.net/biosimilars/news/fda-approves-bevacizumab-biosimilar-avzivi
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves first tocilizumab biosimilar Tofidence [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jun 22]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-tocilizumab-biosimilar-tofidence
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves ustekinumab biosimilar Starjemza [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jun 22]. Available from: www.gabionline.net/biosimilars/news/fda-approves-ustekinumab-biosimilar-starjemza
5. GaBI Online - Generics and Biosimilars Initiative. EC approves golimumab biosimilar Gotenfia and ranibizumab biosimilar Ranluspec [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jun 22]. Available from: www.gabionline.net/biosimilars/news/ec-approves-golimumab-biosimilar-gotenfia-and-ranibizumab-biosimilar-ranluspec
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