Shots:
- The CHMP has granted positive opinion to Opuviz (40mg/mL), a biosimilar to Eylea (aflibercept), for treating wet AMD, visual impairment from macular edema due to RVO, DME & myopic CNV
- The opinion was based on P-III trial in treatment-naïve nAMD patients (n=449), to receive either Opuviz or Eylea & switching b/w the treatments at wk.32. By wk.56, 425 patients completed the study
- The study showed similar efficacy, safety, immunogenicity & PK profile b/w Opuviz vs Eylea. It reached the 1EPs of BCVA improvement at wk.8 as well as 2EPs at wks.32 & 56 confirming the similarity b/w both the drugs
Ref: Samsung Bioepis and Biogen | Image: Samsung Bioepis and Biogen | Press Release
Related News:- Alvotech Reports the Initiation of Confirmatory Trial of AVT16 (Biosimilar, Entyvio)
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