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Regulatory momentum accelerated globally with multiple biosimilars securing key approvals and positive opinions, including Sandoz’s Enzeevu (Eylea biosimilar) in the US and Canada, Accord BioPharma’s Filkri (Neupogen biosimilar) US FDA approval, EC approvals for Gotenfia (Simponi biosimilar) and Ranluspec (Lucentis biosimilar), and CHMP positive opinions for tocilizumab and insulin biosimilars.
Strategic partnerships expanded regional access as companies including Alvotech, Bio-Thera Solutions, Formycon,…
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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…
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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…

