South Korean biopharmaceutical company Samsung Bioepis Co Ltd announced on Friday the launch of OPUVIZ (aflibercept) 40 mg/mL solution for injection in a vial across Europe.

OPUVIZ, an aflibercept biosimilar referencing Regeneron Pharmaceuticals' (NASDAQ:REGN) Eylea, becomes the fifth biosimilar product to be directly commercialised by Samsung Bioepis in Europe.

This launch expands Samsung Bioepis' ophthalmology portfolio in the region following the start of direct commercialisation of BYOOVIZ (ranibizumab) 10 mg/mL solution for injection in a vial, as well as the launch of XBRYK (denosumab) 120 mg solution for injection in a vial, earlier this year.

In January 2026, the company signed a settlement and licence agreement with Regeneron and Bayer (ETR:BAYN) (OTC:BAYRY) regarding commercialisation of its aflibercept biosimilar in Europe and the Rest of the World.

OPUVIZ is approved for adults for the treatment of wet age-related macular degeneration, visual impairment due to retinal vein occlusion, diabetic macular oedema, and myopic choroidal neovascularisation.

OPUVIZ 40 mg/mL solution for injection in pre-filled syringe obtained positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in November 2025 for the same indications as the vial presentation, and is expected to be available in the third quarter of 2026.