Accord BioPharma Reports the US FDA Approval of Immgolis and Immgolis Intri (Biosimilar, Simponi and Simponi Aria)
Shots:
- The US FDA has approved Immgolis & Immgolis Intri, the interchangeable biosimilar versions of Simponi & Simponi Aria (golimumab), respectively
- Immgolis & Immgolis Intri are both approved for the treatment of adults with mod. to sev. active rheumatoid arthritis in combination with methotrexate, while Immgolis is additionally approved for mod. to sev. active ulcerative colitis in adults
- Both biosimilars were developed by Bio-Thera, which will continue managing manufacturing & supply, while Accord BioPharma holds exclusive US commercialization rights, with launches planned for Q4’26
Ref: PRnewswire | Image: Accord BioPharma | Press Release
Related News: Accord BioPharma’s Filkri (Biosimilar, Neupogen) Receives the US FDA Approval
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