FDA Approves Golimumab-Sldi as First Biosimilar for Simponi

The FDA granted approval to golimumab-sldi (Immgolis, Immgolis Intri), marking the arrival of the first biosimilar options for the reference biologics Simponi and Simponi Aria, respectively. Developed by Bio-Thera Solutions and set to be commercialized exclusively in the United States by Accord BioPharma, these products represent a significant shift in the immunology landscape for patients suffering from chronic autoimmune conditions.^1,2

"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," Chrys Kokino, president of Accord North America, said in a news release.¹ "This approval answers a clear demand in the U.S. market and helps advance our ambitious goal to bring 20 biosimilars to market by the year 2030."

For pharmacists, the most critical aspect of this regulatory milestone is that the FDA has designated both products as interchangeable biosimilars. This designation means that, subject to individual state pharmacy laws, these medications may be substituted for their reference products at the pharmacy level without the need for a consultation with the prescribing physician.^1,2

About The Approval

The approval of Immgolis covers the treatment of adult patients with moderately to severely active rheumatoid arthritis when used in combination with methotrexate, as well as those with moderately to severely active ulcerative colitis. Immgolis Intri is specifically approved for adult patients with moderately to severely active rheumatoid arthritis in combination with methotrexate.

These conditions involve the immune system mistakenly attacking healthy cells, leading to painful swelling in the joints or ulcers in the lining of the colon. By acting as tumor necrosis factor alpha blockers, these golimumab products bind to specific proteins to halt the inflammatory process that triggers these debilitating symptoms.²

Immgolis and Immgolis Intri carry a boxed warning regarding the risk of serious infections and malignancy. Patients treated with these products are at an increased risk for developing infections that may lead to hospitalization or death, including tuberculosis, bacterial sepsis, and invasive fungal infections.¹

Pharmacists should ensure that patients have been evaluated for tuberculosis risk factors and tested for latent infection prior to initiating therapy. Furthermore, it is essential to monitor for the reactivation of the hepatitis B virus and to advise patients that live vaccines should not be administered concurrently with golimumab therapy.³

The Role of the Pharmacist

From a clinical and dispensing perspective, pharmacists should note the distinct administration routes for each product. Immgolis is administered via subcutaneous injection and will be supplied in 50 mg/0.5 mL and 100 mg/mL single-dose prefilled syringes. In contrast, Immgolis Intri is intended for intravenous infusion prepared from a 50 mg/4 mL solution in a single-dose vial. Both products require strict temperature management, as golimumab must be refrigerated and should never be frozen. Patients using the subcutaneous version typically self-inject one 50 mg dose every 4 weeks after receiving proper instruction from a health care professional.^1-3

The clinical profile of these new biosimilars is supported by a comprehensive review of scientific evidence, including analytical comparisons and pharmacokinetic similarity studies that demonstrated no clinically meaningful differences between the biosimilars and their reference products.²

Common adverse reactions observed during trials include upper respiratory tract infections, nasopharyngitis, and injection site reactions. Pharmacists should also be aware of potential drug interactions, as the concomitant use of golimumab with other biologic products like abatacept or anakinra is not recommended due to an increased risk of serious infections.¹

"Biosimilars are one of the most powerful tools we have to improve affordability and access across the US health care system," Binish Chudgar, chairman and managing director of Intas Pharmaceuticals, said in the news release.¹ “With Accord BioPharma's deep expertise, dedicated team, and bold vision, the team is well positioned to bring this first-of-its-kind product to U.S. patients and providers later this year."

As these interchangeable products enter the supply chain, pharmacists will play a central role in educating patients on the transition to biosimilars and managing the long-term safety monitoring required for these potent immunomodulatory agents.

READ MORE: Biosimilar Resource Center

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REFERENCES

1. 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. News release. Accord BioPharma. 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. FDA approves first interchangeable biosimilars to Simponi and Simponi Aria (golimumab) to treat rheumatoid arthritis and ulcerative colitis. News release. FDA. 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

3. Johns Hopkins Arthritis Center. Golimumab (Simponi) drug information sheet. Accessed May 18, 2026. https://www.hopkinsarthritis.org/patient-corner/drug-information/golimumab-simponi/