Key takeaways:
- Immgolis is the first interchangeable biosimilar to Simponi.
- It is approved for treatment of adults with moderately to severely active ulcerative colitis.
The FDA has approved golimumab-sldi as the first interchangeable biosimilar to Simponi for ulcerative colitis.
Golimumab-sldi (Immgolis, Accord BioPharma) has been approved as a biosimilar to golimumab (Simponi, Johnson & Johnson) for adults with moderately to severely active ulcerative colitis. It is administered via subcutaneous injection in a single-dose prefilled syringe.
The FDA has approved golimumab-sldi as the first interchangeable biosimilar to Simponi for ulcerative colitis.
The agent also received approval for adults with moderately to severely active rheumatoid arthritis in combination with methotrexate.
Immgolis Intri, a biosimilar to golimumab (Simponi Aria) that is administered via IV infusion, is approved for the same indication.
“As the first golimumab biosimilars approved in the U.S., Immgolis and Immgolis Intri represent a meaningful new option for people in the U.S. who are living with the chronic, debilitating autoimmune conditions associated with moderately to severely active rheumatoid arthritis or ulcerative colitis and need more affordable medication,” Chrys Kokino, president of Accord North America, said in an Accord press release.
The FDA based its approval on “a comprehensive review of scientific evidence demonstrating the products are highly similar to Simponi and Simponi Aria … and that there are no clinically meaningful differences between the two product pairs,” according to an FDA release.
Golimumab-sldi may be substituted for the reference products without consulting the prescriber. The medication should be available in the fourth quarter of 2026.
Common side effects of golimumab-sldi are upper respiratory tract infection, nasopharyngitis and injection site reactions, similar to those for Simponi and Simponi Aria.
Ask a clinical question and tap into Healio AI’s knowledge base.
- PubMed, enrolling/recruiting trials, guidelines
- Clinical Guidance, Healio CME, FDA news
- Healio’s exclusive daily news coverage of clinical data
