Samsung Bioepis and Biogen Report the EC’s Approval of Opuviz (Biosimilar, Eylea)
Shots:
- The EC has granted approval to Opuviz 40 mg/mL solution, biosimilar version of Eylea (aflibercept) and will be commercialized by Biogen as per an agreement b/w the companies
- Approval of SB15 was based on comprehensive data, incl. a P-III study showing equivalent efficacy, safety, immunogenicity & PK profile to aflibercept. It achieved the 1EP of BCVA improvement at wk.8, and interim analyses at wks.32 and 56 confirming its comparability
- Opuviz is indicated to treat wet age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), diabetic macular oedema (DME), and myopic choroidal neovascularization (myopic CNV)
Ref: Samsung Bioepis | Image: Samsung Bioepis
Related News:- The CHMP Grants Positive Opinion to Samsung Bioepis and Biogen’s Opuviz (Biosimilar, Eylea)
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.
