Drug Update · Rheumatology

Golimumab Immgolis Approved as Interchangeable for RA and UC

September 04, 2026

Approval status

FDA approved Immgolis and Immgolis Intri as interchangeable biosimilars to Simponi and Simponi Aria

Approval date

May 2026

Indications

Adult patients with moderately to severely active rheumatoid arthritis (in combination with methotrexate); adult patients with moderately to severely active ulcerative colitis

RA dose

50 mg subcutaneous injection once a month

UC dose

200 mg Week 0, 100 mg Week 2, then 100 mg every 4 weeks

Interchangeability

Designated interchangeable based on analytical comparability and pharmacokinetic similarity

Clinical Perspective

This change affects rheumatologists, gastroenterologists, pharmacists, and other clinicians managing adult patients with moderately to severely active rheumatoid arthritis (in combination with methotrexate) or moderately to severely active ulcerative colitis, for whom golimumab therapy is indicated ^[1]^[2]. The FDA interchangeability designation and the agency’s statement that Immgolis demonstrated comparable analytical attributes and pharmacokinetic exposure support pharmacy-level substitution in accordance with applicable state laws and reliance on biosimilarity and interchangeability data when implementing formulary or substitution policies ^[2]^[4]. What are the real-world effects on switching, including long-term immunogenicity and clinical outcomes, when patients are substituted between Simponi/Simponi Aria and Immgolis under state substitution laws?

Dr. Deepak Nair, MBBS, MD (General Medicine), DM (Clinical Immunology & Rheumatology) · Rheumatology

The FDA approved Immgolis (golimumab-sldi) in May 2026 as an interchangeable biosimilar to Simponi (golimumab) and Immgolis Intri (golimumab-sldi) as an interchangeable biosimilar to Simponi Aria (golimumab) for treatment of adult patients with moderately to severely active rheumatoid arthritis (in combination with methotrexate) and for moderately to severely active ulcerative colitis in adults ^[2]^[1]. The approval was supported by comparative analytical testing and a pharmacokinetic similarity study showing comparable exposure and immunogenicity between Immgolis and the reference products ^[2]. Clinicians should consult current prescribing information for complete dosing guidance.

Clinical Context

Immgolis (golimumab-sldi) is a biosimilar formulation of golimumab, a human monoclonal antibody that binds to tumor necrosis factor alpha (TNFα), inhibiting its activity ^[2]^[5]. The FDA characterizes Immgolis and Immgolis Intri as the first biosimilars approved as interchangeable with Simponi and Simponi Aria, respectively, reflecting additional data supporting switching between the biosimilar and the reference products under the FDA interchangeability standard ^[2]^[3]. The Immgolis prescribing information identifies Accord BioPharma, Inc. for adverse event reporting and provides the approved subcutaneous and intravenous dosage forms and strengths for the respective products ^[1]. The FDA and its educational materials note that interchangeable biosimilars may be substituted at the pharmacy level in accordance with applicable state pharmacy laws ^[4].

Key Findings

The FDA approved Immgolis (golimumab-sldi) as an interchangeable biosimilar to Simponi (golimumab) for adult patients with moderately to severely active rheumatoid arthritis to be used in combination with methotrexate, and for adult patients with moderately to severely active ulcerative colitis; Immgolis Intri (golimumab-sldi) was approved as interchangeable with Simponi Aria for RA indications administered intravenously ^[2]^[1].
The FDA noted that multiple lots of Immgolis and Immgolis Intri were compared across a broad range of product quality attributes with the reference products, and a pharmacokinetic similarity study demonstrated comparable exposure and immunogenicity between Immgolis and Simponi, supporting the interchangeability designation ^[2].
The prescribing information lists the approved dosing for rheumatoid arthritis as 50 mg administered by subcutaneous injection once a month, and the approved dosing regimen for ulcerative colitis as 200 mg at Week 0, 100 mg at Week 2, then 100 mg every 4 weeks thereafter for adults ^[1]. Clinicians should consult current prescribing information for complete dosing guidance.

Safety & Tolerability

Serious infections leading to hospitalization or death including tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving golimumab products; discontinue IMMGOLIS if a patient develops a serious infection or sepsis and test for latent TB before initiating therapy ^[1].
Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers, of which IMMGOLIS is a member ^[1].
In clinical trials, the most common adverse reactions in adults (incidence > 5%) were upper respiratory tract infection, nasopharyngitis, and injection site reactions ^[1].
Hepatitis B virus reactivation has been reported; monitor HBV carriers during and several months after therapy and stop IMMGOLIS if reactivation occurs ^[1].
Worsening or new onset congestive heart failure has been observed; discontinue IMMGOLIS if new or worsening symptoms occur ^[1].
Demyelinating disorders, including new onset or exacerbation, have been reported ^[1].
Lupus-like syndrome has been observed; discontinue IMMGOLIS if symptoms develop ^[1].
Serious systemic hypersensitivity reactions including anaphylaxis may occur ^[1].
Concomitant use with abatacept or anakinra has been associated with a higher risk of serious infections; concomitant use is not recommended ^[1].

Study Design

The FDA approval in May 2026 of Immgolis and Immgolis Intri as interchangeable biosimilars was based on a totality-of-evidence approach including comparative analytical testing across multiple manufacturing lots and a pharmacokinetic similarity study demonstrating comparable exposure and immunogenicity versus the reference products; the FDA press release and product labeling describe these data as supporting interchangeability ^[2]^[1]. Immgolis is supplied as a subcutaneous single-dose prefilled syringe (50 mg/0.5 mL and 100 mg/mL strengths) and Immgolis Intri is supplied as an intravenous product prepared from a single-dose vial, consistent with the reference products’ routes of administration ^[1]^[2]. Clinicians should consult current prescribing information for full dosing guidance. Additional clinical efficacy data for the reference products are provided in the Simponi/Simp on i Aria labeling and clinical trial sections ^[5].

FAQ

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

Immgolis is approved as a biosimilar to Simponi and, per the FDA, as an interchangeable biosimilar to Simponi for adult patients with moderately to severely active rheumatoid arthritis to be used in combination with methotrexate, and as a biosimilar to Simponi for the treatment of moderately to severely active ulcerative colitis in adults. Immgolis Intri was approved as an interchangeable biosimilar to Simponi Aria for RA indications. These approvals were announced by the FDA in May 2026.

Q2 How does Immgolis work?

Immgolis contains golimumab, a human monoclonal antibody that binds both soluble and transmembrane forms of tumor necrosis factor alpha (TNFα). By binding TNFα, golimumab prevents TNFα from interacting with its receptors and inhibits downstream inflammatory signaling that contributes to disease activity in conditions such as rheumatoid arthritis and ulcerative colitis, consistent with the mechanism described for golimumab reference products.

Q3 What is the recommended dose of Immgolis?

For rheumatoid arthritis in adults, the approved Immgolis dose is 50 mg administered by subcutaneous injection once a month. For adults with moderately to severely active ulcerative colitis, the recommended subcutaneous induction and maintenance regimen is 200 mg at Week 0, 100 mg at Week 2, then 100 mg every 4 weeks thereafter. Clinicians should consult current prescribing information for complete dosing guidance.

Q4 What are the most common side effects?

The most common adverse reactions observed in adults (incidence > 5%) are upper respiratory tract infection, nasopharyngitis, and injection site reactions. More serious adverse events reported with golimumab products include serious infections (including tuberculosis and invasive fungal infections), malignancies including lymphoma in pediatric patients, hepatitis B reactivation, worsening or new onset congestive heart failure, demyelinating disorders, lupus-like syndrome, and serious hypersensitivity reactions including anaphylaxis. For full safety information and monitoring recommendations, refer to the full prescribing information.

Golimumab Immgolis Approved as Interchangeable for RA and UC

Direct Clinical Takeaway & Evidence Summary

Golimumab Immgolis Approved as Interchangeable for RA and UC

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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