FDA Approves First Golimumab Biosimilars to Treat RA and UC
The FDA has approved two golimumab biosimilars, Immgolis and Immgolis Intri, for the treatment of rheumatoid arthritis and ulcerative colitis. These biosimilars are now interchangeable with the reference products Simponi and Simponi Aria. The approvals mark a significant step in expanding treatment options for patients with these conditions.
- ▪The FDA approved Immgolis and Immgolis Intri as interchangeable biosimilars for Simponi and Simponi Aria.
- ▪Immgolis is administered via subcutaneous injection, while Immgolis Intri is given as an intravenous infusion.
- ▪The approvals are based on extensive comparisons of product quality attributes and a pharmacokinetic similarity study.
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The FDA has approved two TNF inhibitor golimumab-sldi biosimilars, Immgolis and Immgolis Intri, as interchangeable with the golimumab reference products Simponi and Simponi Aria, according to an announcement from the agency on May 15.The Simponi approval is for the treatment of adults with active, moderate-to-severe rheumatoid arthritis (RA) and active, moderate-to-severe ulcerative colitis (UC), whereas Simponi Aria’s approval is for only RA.The approvals make Immgolis and Immgolis Intri the first biosimilars approved for Simponi and Simponi Aria, respectively.
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