FDA Approves First Golimumab Biosimilars from Accord BioPharma

Accord BioPharma, the US specialty division of Intas Pharmaceuticals, announced that FDA has approved golimumab-sldi under the brand names Immgolis and Immgolis Intri, the first biosimilars to Johnson & Johnson’s golimumab (Simponi and Simponi Aria, respectively) in the United States. The agency has also designated both biosimilars as interchangeable for rheumatoid arthritis and ulcerative colitis. The company expects to make the products commercially available in the fourth quarter of 2026.¹

“As the first golimumab biosimilars approved in the US, [Immgolis] and [Immgolis Intri] represent a meaningful new option for people in the US who are living with the chronic, debilitating autoimmune conditions associated with moderately to severely active rheumatoid arthritis or ulcerative colitis and need more affordable medication,” said Chrys Kokino, president of Accord North America in a company press release.¹

What indications were approved for the golimumab biosimilars?

Immgolis and Immgolis Intri are tumor necrosis factor (TNF) blockers approved for select inflammatory disease indications. TNF blockers neutralize TNF-α, a central proinflammatory cytokine. In doing so, they reduce downstream cytokine release, leukocyte activation, and synovial/tissue inflammation that drive diseases such as rheumatoid arthritis and inflammatory bowel disease.²

According to the company, Immgolis is indicated for adults with moderately to severely active rheumatoid arthritis when used with methotrexate and for adults with moderately to severely active ulcerative colitis. Immgolis Intri is approved for adults with moderately to severely active rheumatoid arthritis in combination with methotrexate.

The biosimilars are not approved for certain additional indications associated with the reference products, including psoriatic arthritis, ankylosing spondylitis, and several pediatric indications, according to the company.

How does the approval affect biosimilar access in rheumatology and gastroenterology?

The approval marks the first biosimilar competition for golimumab therapies in the US, expanding treatment options for patients receiving biologic therapies for autoimmune disease. The company stated that the approvals support broader patient access to biologic medicines and align with the company’s long-term biosimilar commercialization strategy.¹

“Biosimilars are one of the most powerful tools we have to improve affordability and access across the US healthcare system,” said Binish Chudgar, chairman and managing director of Intas Pharmaceuticals, in the release.¹ “[Accord BioPharma's] team is well positioned to bring this … product to US patients and providers later this year.”

The two biosimilars will be commercialized exclusively in the US by Accord BioPharma. Immgolis and Immgolis Intri each carry boxed warnings for serious infections and malignancy, consistent with reference golimumab products.

What role did Bio-Thera Solutions play in development?

The biosimilars were developed by China-based biopharmaceutical company Bio-Thera Solutions, which will remain responsible for manufacturing and product supply activities, according to Accord BioPharma.¹

These approvals are part of the company’s broader effort to expand its biosimilar portfolio in oncology, immunology, and central nervous system disorders. The company aims to bring 20 biosimilars to the US market by 2030.

In addition to the newly approved golimumab biosimilars, Accord BioPharma’s current portfolio includes biosimilars referencing pegfilgrastim, ustekinumab, trastuzumab, filgrastim, and denosumab products.

References

1. Accord BioPharma. FDA approves IMMGOLIS (golimumab-sldi) and IMMGOLIS INTRI (golimumab-sldi), first biosimilars to Simponi (golimumab) and Simponi Aria (golimumab); Accord BioPharma to lead US commercialization. Published May 18, 2026. Accessed May 18, 2026. https://www.accordbiopharma.com/news/fda-approves-immgolis-golimumab-sldi-and-immgolis-intri-golimumab-sldi-first-biosimilars-to-simponi-golimumab-and-simponi-aria-golimumab-accord-biopharma-to-lea/
2. Gerriets V, Goyal A, Khaddour K. Tumor necrosis factor inhibitors. [Updated 2023 Jul 3]. In StatPearls [Internet]. StatPearls Publishing; 2026. https://www.ncbi.nlm.nih.gov/books/NBK482425/