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
Related News:- Celltrion’s Omlyclo (CT-P39) Secures the Health Canada’s Approval (Biosimilar, Xolair)
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
