Shots:FDA has accepted BLA for BAT2506, a biosimilar of Simponi (golimumab) for all approved doses, formulations, & indications of reference product, with a request for interchangeability (BsUFA: May 16, 2026)BLA was backed by extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects,…
