Golimumab is a tumor necrosis factor (TNF) blocker used for immune-mediated inflammatory diseases. U.S. marketed brands include Simponi and Simponi Aria. It was first approved by the FDA on April 24, 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.
Bio-Thera Solutions expands its partnership with Intas Pharmaceuticals for BAT2506, a golimumab biosimilar, through an exclusive commercialization agreement for India. The India biosimilars market is projected to grow from $184 million to $1.02 billion by 2035, driven by patent expirations and strategic partnerships.
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 |
|---|---|---|---|
| NCT07138898 |
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
NOT_YET_RECRUITING | PHASE2 |
| NCT05960578 |
Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT05669833 |
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients |
RECRUITING | PHASE3 |
| NCT05242484 |
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT05242471 |
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT05164198 |
REduCed Dose of TNFi in Patients With Ankylosing SpondyliTis (RECAST) |
UNKNOWN | PHASE4 |
| NCT05071664 |
A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis |
COMPLETED | PHASE2 |
| NCT04729296 |
Anti-TNFα to Delay or Prevent Progression to Stage 3 T1D |
WITHDRAWN | PHASE2 |
| NCT04725422 |
CHronic Nonbacterial Osteomyelitis International Registry |
RECRUITING | |
| NCT04610476 |
Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis |
UNKNOWN | PHASE3 |
