Shots:
- The EC has approved STADA & Bio-Thera’s Gotenfia (BAT2506; 50mg/0.5mL & 100mg/mL PFS), a biosimilar version of Simponi (golimumab), in all 30 EEA states, with launch preparations ongoing
- Approval was based on extensive analytical, non-clinical & clinical data demonstrating biosimilarity of BAT2506 to Simponi
- In May 2024 deal, STADA obtained exclusive commercial rights to Gotenfia in the EU, UK, Switzerland & selected other countries, while Bio-Thera handled its development, manufacturing, & supply, expanding it to cover tocilizumab biosimilar (in 2025) for which launch preparations are also underway
Ref: PRnewswire | Image: STADA & Bio-Thera |Press Release
Related News: Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across Canada
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