Shots:
- The EC has approved Eydenzelt (CT-P42, aflibercept), a biosimilar to Eylea, Stoboclo & Osenvelt (CT-P41, denosumab), a biosimilar to Prolia & Xgeva for all indications of the reference products
- The P-III trial of Eydenzelt (40 mg/mL solution for injection in a vial & pre-filled syringe) vs Eylea (aflibercept) in diabetic macular edema (DME) patients achieved its predefined equivalence criteria and 2EP of equivalent efficacy, safety & immunogenicity
- The P-III study of Stoboclo (60 mg solution for injection in pre-filled syringe) & Osenvelt (120 mg solution in a vial) vs Prolia & Xgeva (denosumab) in patients (n=479) achieved its 1EP, showing equivalent efficacy plus similar PK/PD, safety & immunogenicity
Ref: Celltrion | Image: Celltrion
Related News:- Celltrion Secures the US FDA’s Approval for Avtozma IV/SC (Biosimilar, Actemra)
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