Drug Update · Rheumatology

Golimumab Biosimilars Update: FDA OKs Interchangeable Immgolis for RA and UC

August 10, 2026

FDA action

Approved Immgolis (golimumab-sldi) interchangeable to Simponi; Immgolis Intri interchangeable to Simponi Aria [8][7]

ACR20 Week 14 (Trial RA)

59% (SIMPONI ARIA + MTX) vs 25% (placebo + MTX) [11]

Radiographic change vdH-S Week 24

Mean change 0.03 (SIMPONI ARIA + MTX) vs 1.1 (placebo + MTX); p≤0.001 [11]

Clinical Perspective

For rheumatologists, pharmacists, and advanced practice providers treating adults with moderately to severely active rheumatoid arthritis or ulcerative colitis, the FDA’s approvals add interchangeable golimumab biosimilars (Immgolis and Immgolis Intri) to the therapeutic armamentarium and may expand access to subcutaneous and intravenous golimumab formulations ^[2]^[1]. The regulatory decision was supported by demonstration of biosimilarity, pharmacokinetic comparability, and analytical similarity; clinicians can expect safety profiles consistent with the reference golimumab products as stated by the FDA ^[2]^[5]. How these interchangeable approvals will affect formulary placement, substitution practices at the pharmacy level, and payer coverage for individual practices and patients remains to be determined and was not reported in the provided source excerpts.

Dr. Deepak Nair · Rheumatology

The FDA approved Immgolis (golimumab-sldi) as an interchangeable biosimilar to Simponi and Immgolis Intri (golimumab-sldi) as an interchangeable biosimilar to Simponi Aria. Immgolis is approved for adult patients with moderately to severely active rheumatoid arthritis in combination with methotrexate and for adult patients with moderately to severely active ulcerative colitis; Immgolis Intri is approved for adults with rheumatoid arthritis in combination with methotrexate ^[2].

Clinical Context

Golimumab is a human monoclonal antibody that binds both soluble and transmembrane forms of tumor necrosis factor alpha (TNFα), preventing TNFα from binding its receptors and inhibiting TNFα biological activity ^[5]. Simponi and Simponi Aria are golimumab reference products used in inflammatory diseases including rheumatoid arthritis and ulcerative colitis; the SIMPONI ARIA label describes intravenous administration and clinical trial evidence in RA ^[5]. The FDA emphasizes that biosimilar and interchangeable approvals are intended to increase treatment options and potentially lower costs and improve access to biologic therapies; the agency has also published guidance to streamline biosimilar development and reduce unnecessary clinical testing ^[1]^[3]^[4]. Information on adalimumab and etanercept biosimilars, switching protocols beyond interchangeability for golimumab, and cost or payer-specific access details were not reported in the provided source excerpts.

Key Findings

The FDA approved Immgolis (golimumab-sldi) as an interchangeable biosimilar to Simponi and Immgolis Intri as an interchangeable biosimilar to Simponi Aria; Immgolis is approved for adult patients with moderately to severely active rheumatoid arthritis (in combination with methotrexate) and for adult patients with moderately to severely active ulcerative colitis; Immgolis Intri is approved for adult patients with moderately to severely active rheumatoid arthritis (in combination with methotrexate) ^[2]^[1].
The SIMPONI ARIA randomized, double-blind, controlled Trial RA (NCT00973479) evaluated IV golimumab 2 mg/kg + methotrexate versus placebo + methotrexate in 592 patients with moderately to severely active rheumatoid arthritis; the trial reported 59% ACR20 at Week 14 for SIMPONI ARIA + MTX versus 25% for placebo + MTX (difference 25.9 to 41.4) and greater ACR50 and ACR70 responses at prespecified visits ^[5].
Clinicians should consult current prescribing information for full dosing guidance.
Radiographic outcomes in Trial RA showed inhibition of structural damage: mean change in total van der Heijde-Modified Sharp (vdH-S) score at Week 24 was 0.03 in the SIMPONI ARIA + MTX group versus 1.1 in placebo + MTX (p≤0.001) ^[5].
The FDA’s biosimilar policy updates aim to streamline development, including removing routine requirements for some comparative clinical PK or switching studies when scientifically justified, and noted that reducing unnecessary testing can lower development costs and support broader biosimilar availability ^[3]^[4].

Safety & Tolerability

The FDA noted that the expected side effects for Immgolis and Immgolis Intri are consistent with those observed with Simponi and Simponi Aria; the most common expected side effects include upper respiratory tract infection, nasopharyngitis, and injection site reactions (incidence >5%) ^[2].
The FDA cautioned that golimumab products can cause serious side effects including serious infections and malignancy, and that patients treated with golimumab products are at increased risk for developing serious infections that may lead to hospitalization or death ^[2].

Study Design

The pivotal clinical efficacy data for reference golimumab in rheumatoid arthritis derive from Trial RA (NCT00973479), a multicenter, randomized, double-blind, controlled trial of 592 adults with moderately to severely active RA despite methotrexate. Patients were randomized to receive SIMPONI ARIA 2 mg/kg IV (N=395) or placebo (N=197) with background weekly MTX; primary endpoint was ACR20 at Week 14 with efficacy analyzed through Week 52, and radiographic change (vdH-S) assessed at Week 24 ^[5]. Clinicians should consult current prescribing information for full dosing guidance. The FDA interchangeable approval for Immgolis and Immgolis Intri was based on the totality of evidence demonstrating similarity in structural and functional attributes and comparable pharmacokinetic exposure and immunogenicity; specific PK and analytical study details supporting interchangeability were summarized by the FDA ^[2]^[1].

FAQ

Q1 What is Immgolis (golimumab-sldi) approved for?

Immgolis (golimumab-sldi) is approved by the FDA as an interchangeable biosimilar to Simponi for adults with moderately to severely active rheumatoid arthritis in combination with methotrexate and for adults with moderately to severely active ulcerative colitis. Immgolis Intri is approved as an interchangeable biosimilar to Simponi Aria for adults with moderately to severely active rheumatoid arthritis in combination with methotrexate.

Q2 How does golimumab work?

Golimumab is a human monoclonal antibody that binds both soluble and transmembrane forms of tumor necrosis factor alpha (TNFα). By binding TNFα, golimumab prevents TNFα from engaging its receptors and inhibits downstream TNFα-mediated proinflammatory signaling, a mechanism described for the reference golimumab products.

Q3 What is the recommended dose of Immgolis?

Dosing information for Immgolis and Immgolis Intri was not available in the provided source excerpts. The SIMPONI ARIA intravenous regimen described in the reference label is 2 mg/kg given as an IV infusion at weeks 0 and 4, then every 8 weeks thereafter when used with methotrexate in adults with RA; specific dosing for the biosimilars should be obtained from the biosimilar prescribing information. Clinicians should consult current prescribing information for complete dosing guidance.

Q4 What are the most common side effects of golimumab products?

The FDA stated that the most common expected side effects of Immgolis and Immgolis Intri, consistent with Simponi and Simponi Aria, include upper respiratory tract infection, nasopharyngitis, and injection site reactions (incidence >5%). The FDA also warns that golimumab products can cause serious infections and malignancy; patients treated with golimumab products are at increased risk for serious infections that may lead to hospitalization or death, consistent with the reference product safety profile.

Clinicians should consult current prescribing information for complete dosing guidance.

Golimumab Biosimilars Update: FDA OKs Interchangeable Immgolis for RA and UC

Direct Clinical Takeaway & Evidence Summary

Golimumab Biosimilars Update: FDA OKs Interchangeable Immgolis for RA and UC

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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