FDA Approves First Biosimilars Interchangeable With Simponi/Simponi Aria

This article was originally published by Managed Healthcare Executive. This version has been lightly edited.

FDA approved | Image credit: Ticha - stock.adobe.com

The FDA has approved interchangeable biosimilars that reference Johnson & Johnson’s Simponi and Simponi Aria, which treat patients with rheumatoid arthritis and ulcerative colitis.

Immgolis (golimumab-sldi) is administered by subcutaneous injection in a single-dose, prefilled syringe. Immgolis Intri (golimumab-sldi) is administered as an intravenous infusion prepared from a single-dose vial. As interchangeable biosimilars, Immgolis and Immgolis Intri can be substituted at the pharmacy for patients with rheumatoid arthritis and ulcerative colitis.

Immgolis and Immgolis Intri were developed by Bio-Thera Solutions, which will maintain responsibility for manufacturing and product supply. The biosimilars will be marketed in the United States by Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals. They will be available in the fourth quarter of this year.

Golimumab products are human monoclonal antibodies that bind to a protein called tumor necrosis factor alpha (TNFα). By binding TNFα, golimumab stops it from triggering inflammation, which helps improve signs and symptoms of these diseases. Immgolis and Immgolis Intri have the same indications as Simponi and Simponi Aria. The prescribing information can be found here.

In a news release, the FDA said that the approval of Immgolis and Immgolis Intri was based on the totality of evidence. Comparisons of the biosimilars with Simponi were made across a range of structural and functional product quality attributes and the impact on safety and efficacy.

The most common expected side effects of Immgolis/Immgolis Intri, like Simponi/Simponi Aria, are upper respiratory tract infection, nasopharyngitis, and injection site reactions.