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, plus P-III trial (vs EU Simponi) in active PsA pts depicting non-inferior efficacy & comparable PK, safety, & immunogenicity of BAT2506
- Accord BioPharma (Intas’ US division) submitted the BLA for BAT2506 & will be the MA holder under a Feb 2025 Deal with Bio-Thera, which will handle development & manufacturing of BAT2506, while Accord will lead US commercialization
Ref: Prnewswire | Image: Bio-Thera| Press Release
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