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Celltrion Secures the CHMP’s Positive Opinion for Eydenzelt (Biosimilar, Eylea), Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva) and Avtozma (Biosimilar, RoActemra)

Shots: 

  • The P-III trial of Eydenzelt vs Eylea (aflibercept) in diabetic macular edema (DME) patients achieved its 1EP of BCVA improvement at wk.8, demonstrating equivalent efficacy, safety & immunogenicity 
  • The P-III study of Stoboclo & Osenvelt vs Prolia & Xgeva (denosumab) in patients (n=479) achieved its 1EP, showing equivalent efficacy in lumbar spine bone mineral density (BMD) plus similar PK/PD, safety & immunogenicity 
  • The P-III trial of Avtozma vs RoAtemra (tocilizumab) in mod. to sev. rheumatoid arthritis patients (n=479), depicted equivalent efficacy based on DAS28-ESR scores at wk.12, as well as a sustained efficacy & a comparable safety for up to wk.52 

Ref: Celltrion | Image: Celltrion| Press Release

Related News:- Celltrion’s Omlyclo (CT-P39) Secures the Health Canada’s Approval (Biosimilar, Xolair) 

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