The CHMP Grants Positive Opinion to Samsung Bioepis and Biogen’s Opuviz (Biosimilar, Eylea)
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 | Image: Samsung Bioepis
Related News:- Xbrane Biopharma Reclaims Rights of BIIB801 (Biosimilar, Cimzia) from Biogen
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
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.