FDA
FDA approves first interchangeable biosimilars to Simponi and Simponi Aria
Golimumab therapies are widely used for inflammatory diseases such as rheumatoid arthritis and ulcerative colitis, but until now no interchangeable biosimilars had been available.
On May 12, 2026, FDA approved Immgolis (golimumab-sldi) as an interchangeable biosimilar to Simponi (golimumab) and Immgolis Intri (golimumab-sldi) as an interchangeable biosimilar to Simponi Aria (golimumab). Immgolis is administered as a subcutaneous injection, while Immgolis Intri is given as an intravenous infusion.
Immgolis was approved for adults with moderately to severely active rheumatoid arthritis in combination with methotrexate and for moderately to severely active ulcerative colitis. Immgolis Intri was approved for adults with moderately to severely active rheumatoid arthritis in combination with methotrexate.
The approval is clinically important because interchangeable biosimilars may be substituted for the reference product at the pharmacy level, subject to state laws, without requiring direct prescriber authorization. FDA noted that interchangeable biosimilars are expected to provide the same safety and effectiveness as the reference products.
Approval was based on analytical, functional, pharmacokinetic, and immunogenicity comparisons demonstrating no clinically meaningful differences between the biosimilars and the reference golimumab products. FDA stated that structural and functional similarity was confirmed across multiple product quality attributes known to affect efficacy and safety.
Safety findings were consistent with the established golimumab profile. Common adverse effects included upper respiratory tract infection, nasopharyngitis, and injection-site reactions. Clinicians should continue monitoring for serious infections and malignancy risk associated with TNF-α inhibitors.
Source: U.S. Food and Drug Administration. (2026, May 12). Press release. FDA approves first interchangeable biosimilars to Simponi and Simponi Aria (golimumab) to treat rheumatoid arthritis and ulcerative colitis