Shots:
- The CHMP has recommended STADA & Bio-Thera’s Gotenfia (BAT2506; 50mg/0.5mL & 100mg/mL PFS), a biosimilar version of Simponi (golimumab), for EC approval valid in all 30 EEA states
- Opinion was based on extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects, plus P-III trial (vs Simponi) in active PsA pts depicting non-inferior efficacy & comparable PK, safety, & immunogenicity of BAT2506
- In a 2024 deal, STADA obtained exclusive commercial rights to BAT2506 in the EU, UK, Switzerland & selected other countries, while Bio-Thera handled its development, manufacturing, & supply, expanding it later to cover BAT1806 (Biosimilar, RoActemra)
Ref: Bio-Thera | Image: STADA & Bio-Thera | Press Release
Related News: STADA Receives the CHMP’s Positive Opinion for Kefdensis and Zvogra (Biosimilar, Prolia & Xgeva)
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
