Bio-Thera Reports the EMA’s MAA Acceptance of BAT2506 (Biosimilar, Simponi)
Shots:
- The EMA has accepted the MAA of BAT2506, a biosimilar version of Simponi (golimumab)
- Approval was backed by extensive analytical characterization and biosimilarity of BAT2506 in comparison to US & EU golimumab 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
- MAA was preceded by Bio-Thera & STADA commercialization & license agreement (May 28, 2024), granting STADA exclusive regulatory & commercial rights for BAT2506 in the EU, UK, Switzerland, & other specific regions, while Bio-Thera handles its development, manufacturing, & supply
Ref: Prnewswire | Image: Bio-Thera
Related News:- Bio-Thera Solutions and Tabuk Pharmaceuticals Join Forces to Commercialize BAT2206 (Biosimilar, Stelara) in Saudi Arabia
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