BAT2506 is a proposed biosimilar to golimumab (Simponi) under regulatory review in the United States. The candidate is being developed for autoimmune indications aligned with the reference product, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. As of the cited source, the FDA had accepted the BLA but had not yet approved the product.
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 |
|---|---|---|---|
| NCT05046431 |
Comparative Study of BAT2506 With Simponi® in Participants With Active Psoriatic Arthritis |
COMPLETED | PHASE3 |
