The U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi (golimumab). The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is May 16, 2026. The BLA was submitted by Bio-Thera’s US commercialization partner Accord BioPharma, who will be the MA holder if BAT2506 is approved by FDA.  Accord BioPharma filed the BLA with FDA on May 16, 2025.  The BLA requests approval for all approved pre...