Prefilled Syringe of Byooviz Gains Positive CHMP Opinion — Samsung Bioepis said it expects the Byooviz prefilled syringe to be available in Europe in Q2-2026.

South Korea’s Samsung Bioepis announced Dec. 2 that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended approval of a prefilled syringe of its ophthalmic biosimilar Byooviz.

Byooviz, which references Lucentis (ranibizumab), was first approved in the EU in August 2021 as a single-use vial for intravitreal injection in patients with visual impairment due to wet age-related macular degeneration, diabetic macular edema, proliferative diabetic retinopathy, retinal vein occlusion, and choroidal neovascularization.

Samsung Bioepis said a prefilled syringe is regarded as the standard of care in ophthalmology, providing convenience, precise dosing, ease of use, and safety benefits vs. vials. The company expects the syringe to be available in Europe in Q2-2026.

Samsung Bioepis announced in October 2025 that it would assume responsibility for the marketing of Byooviz in Europe upon the transfer of commercial rights from Biogen, as of January 2026.

Samsung Bioepis and Biogen, of Cambridge, Massachusetts, had been collaborating since 2019 on Byooviz and Opuviz, an Eylea (aflibercept) biosimilar, in the US, Canada, Europe, Japan, and Australia. Harrow secured US rights to Byooviz and Opuviz in July 2025.

Byooviz has been commercially available in several European countries since March 2023. Biogen reported global 2024 revenue from Byooviz of $36.6 million.

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