Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 21 hours ago
- 1 min read
18/05/2026
FDA approved IMMGOLIS™ and IMMGOLIS INTRI™ biosimilars for RA and UC (Ref)
Accord Biopharma announced that the US FDA had approved IMMGOLIS™ (golimumab-sldi) and IMMGOLIS INTRI™ (golimumab-sldi) biosimilar for rheumatoid arthritis (RA) and ulcerative colitis (UC).
IMMGOLIS™ (golimumab-sldi), a biosimilar to Simponi® (golimumab), was approved for the treatment of adult patients with moderately to severely active RA in combination with methotrexate, and adult patients with moderately to severely active UC.
IMMGOLIS INTRI™ (golimumab-sldi), a biosimilar to Simponi Aria® (golimumab), was approved for the treatment of adults with moderately to severely active RA in combination with methotrexate.
Accord BioPharma expanded its growing biosimilar portfolio as the exclusive US commercialization partner for IMMGOLIS and IMMGOLIS INTRI.
Accord Biopharma planned to make these products available to patients and providers in Q4 2026.
Simponi and Simponi Aria carried black box warnings.
