European Commission Approves Samsung Bioepis and Biogen’s Aflibercept Biosimilar

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On November 18, 2024, Samsung Bioepis announced that the European Commission (EC) has approved its aflibercept biosimilar, OPUVIZ.  Referencing Regeneron’s biosimilar product EYLEA, OPUVIZ is a 40 mg/mL solution for injection, approved for the treatment of neovascular age related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema, and visual impairment due to myopic choroidal neovascularization.  OPUVIZ was developed by Samsung Bioepis, and Biogen holds commercialization rights to the product in the United States.  OPUVIZ is the second EC-approved ophthalmology biosimilar under Samsung Bioepis and Biogen’s partnership.

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