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news.Samsung Bioepis is set take over the European commercialisation of Byooviz (ranibizumab) from January 2026 under an asset purchase agreement (APA) with Biogen.
The transfer returns commercial rights for the therapy to Samsung Bioepis. Credit: Nappy on Unsplash.
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The agreement covers Samsung Bioepis’ two ophthalmology assets, Byooviz (ranibizumab) and Opuviz (aflibercept), in Europe.
The transfer returns commercial rights for Byooviz to Samsung Bioepis and positions the company to directly manage market activities across the region.
Byooviz is a biosimilar that references Lucentis (ranibizumab), while Opuviz is a biosimilar that references Eylea (aflibercept).
Byooviz received European Commission (EC) approval in August 2021 as the first ophthalmology biosimilar in Europe for myopic choroidal neovascularisation, neovascular (wet) age-related macular degeneration, and macular oedema following retinal vein occlusion.
It became commercially available in several European countries from March 2023.
Samsung Bioepis executive vice-president and commercial global head Linda Choi MacDonald said: “We are pleased to announce our direct commercialisation initiative for Byooviz in Europe.
“We will work closely with Biogen to ensure a seamless transition and the continued delivery of services to our customers and patients in Europe. Samsung Bioepis will continue to broaden our reach to patients across Europe by reinforcing our leadership and expertise in biosimilars.”
Opuviz was approved by the EC in November 2024 and by the Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025 for visual impairment due to myopic choroidal neovascularisation, visual impairment due to diabetic macular oedema, visual impairment due to macular oedema secondary to retinal vein occlusion, and wet age-related macular degeneration.
Opuviz will not launch until relevant Eylea patent(s) lapse or are revoked in Europe.
