Simponi is the brand name for golimumab, a TNF blocker indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and moderately to severely active ulcerative colitis in adults and eligible pediatric patients. The label describes golimumab as binding soluble and transmembrane TNF-alpha to inhibit TNF biological activity. U.S. initial approval was in 2009.
Alvotech said it will release first-quarter 2026 financial results on May 6, 2026, and host a webcast with live Q&A on May 7. The company said five biosimilars are already approved and marketed, with nine disclosed candidates in development.
The European Commission has approved Gotenfia (golimumab), a biosimilar to Simponi developed by Bio-Thera and marketed by STADA, for chronic inflammatory autoimmune diseases across the EU and EEA.
The European Commission has granted marketing authorization for Gotenfia, a golimumab biosimilar to Simponi, developed by Bio-Thera and to be commercialized by STADA across the EU, EEA, UK, Switzerland and selected other countries.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT01313858 |
A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554) |
COMPLETED |
