The US Food and Drug Administration approved Immgolis (golimumab-sldi) and Immgolis Intri (golimumab-sldi) as the first interchangeable biosimilars to Simponi (golimumab) and Simponi Aria (golimumab), respectively, for rheumatoid arthritis and, in the case of Immgolis, ulcerative colitis in adult patients, according to the US Food and Drug Administration.
Immgolis received approval for use in adults with moderately to severely active rheumatoid arthritis in combination with methotrexate and in adults with moderately to severely active ulcerative colitis. Immgolis Intri was approved for adults with moderately to severely active rheumatoid arthritis in combination with methotrexate. Immgolis is administered as a subcutaneous injection in a prefilled syringe, whereas Immgolis Intri is administered as an intravenous infusion from a single-dose vial.
Golimumab products are monoclonal antibodies that inhibit tumor necrosis factor alpha.
The US Food and Drug Administration stated that approval was supported by analytical, structural, functional, and pharmacokinetic comparisons demonstrating that the biosimilars were highly similar to the reference products without clinically meaningful differences in safety, purity, or potency. Comparative assessments included physicochemical testing, biologic assays, and evaluation of multiple manufacturing lots. Pharmacokinetic analyses demonstrated similar exposure and immunogenicity profiles between Immgolis and Simponi.
Under US Food and Drug Administration standards, interchangeable biosimilars meet additional regulatory requirements permitting pharmacy-level substitution, subject to state pharmacy laws. The agency noted that interchangeable biosimilars are expected to provide comparable clinical outcomes to their reference biologics and may offer lower-cost treatment alternatives.
The safety profile of Immgolis and Immgolis Intri was consistent with that reported for Simponi and Simponi Aria. Common adverse events included upper respiratory tract infection, nasopharyngitis, and injection-site reactions. Golimumab products can cause serious infections and malignancies.
Source: FDA