Opuviz is latest EC-approved ophthalmology biosimilar
Following US approval in May this year, South Korea’s Samsung Bioepis and US biotech Biogen (Nasdaq: BIIB) have now won approval from the European Commission (EC) for their Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing Regeneron (Nasdaq: REGN) and Bayer’s (BAYN: DE) Eylea (aflibercept).
Opuviz, also known as SB15, is approved in adult patients for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV).
“Retinal disorders are affecting millions of people’s lives in Europe, yet many patients face barriers to treatment due to high costs,” said Byoungin Jung, vice president, regulatory affairs at Samsung Bioepis, which developed the biosimilar.
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