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 and Biogen | Image: Samsung Bioepis and Biogen | Press Release
Related News:- Sandoz Report the EC’s Approval of Afqlir (Biosimilar, Eylea) to Treat Neovascular Age-related Macular Degeneration (nAMD)
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