Posted by Michael Wonder on 19 Jul 2025
Bio-Thera Solutions announces FDA accepts biologics license application for BAT2506, a proposed biosimilar to Simponi
16 July 2025 - Bio-Thera Solutions today announced that the US FDA has accepted its biologics license application for BAT2506, a proposed biosimilar to Simponi (golimumab).
The FDA Biosimilar User Fee Act (BsUFA) goal date is 16 May 2026.
