FDA Clears Golimumab Biosimilars
New biosimilars enter the market with pharmacy-level substitution eligibility for rheumatology and gastroenterology indications.
By
Kathryn Wighton
May 18, 2026
Clinical Scorecard: FDA Clears Golimumab Biosimilars
At a Glance
Category Detail
Condition Rheumatoid Arthritis and Ulcerative Colitis Key Mechanisms Monoclonal antibodies inhibiting tumor necrosis factor alpha Target Population Adults with moderately to severely active rheumatoid arthritis and ulcerative colitis Care Setting Outpatient settings for subcutaneous and intravenous administration
Key Highlights
Approval of Immgolis and Immgolis Intri as interchangeable biosimilars to Simponi and Simponi Aria Immgolis approved for rheumatoid arthritis and ulcerative colitis; Immgolis Intri for rheumatoid arthritis only Biosimilars demonstrated high similarity to reference products with no clinically meaningful differences Interchangeable biosimilars allow pharmacy-level substitution under state laws Common adverse events include upper respiratory tract infection and injection-site reactions Guideline-Based Recommendations
Diagnosis
Assess disease activity in rheumatoid arthritis and ulcerative colitis Management
Use Immgolis in combination with methotrexate for rheumatoid arthritis and ulcerative colitis Monitoring & Follow-up
Monitor for infections and malignancies during treatment Risks
Risk of serious infections and malignancies associated with golimumab products Patient & Prescribing Data
Adults with moderately to severely active rheumatoid arthritis and ulcerative colitis
Biosimilars may offer lower-cost treatment alternatives with comparable clinical outcomes
Clinical Best Practices
Ensure proper administration technique for subcutaneous and intravenous formulations Educate patients on potential adverse effects and signs of serious infections Related Resources & Content
