Samsung Bioepis has started direct commercialization of BYOOVIZ, a biosimilar to Lucentis (ranibizumab), across Europe, marking a significant shift in the company’s regional strategy. The move follows the transfer of commercial rights from Biogen back to Samsung Bioepis and positions BYOOVIZ as a Samsung Bioepis–branded product in multiple European markets.
The company said it has worked closely with stakeholders to ensure a smooth transition of commercial responsibilities, aiming to avoid disruption in patient access. With the change, Samsung Bioepis will now oversee commercialization activities directly, allowing it to engage more closely with payers, healthcare professionals, and health systems across Europe.
Antonio Rito, Vice President and Head of Europe at Samsung Bioepis, described the development as an important milestone in the company’s long-term growth plan. He noted that the direct launch of BYOOVIZ builds on Samsung Bioepis’ recent experience with other directly commercialized products in Europe, including EPYSQLI (eculizumab) over the past three years, as well as the more recent launches of OBODENCE and XBRYK, both biosimilars to denosumab. According to Rito, these efforts support the company’s ambition to become a fully integrated biopharmaceutical organization with end-to-end capabilities spanning development, manufacturing, and commercialization.
BYOOVIZ was originally approved by the European Commission in August 2021 as a single-use vial for intravitreal injection at a dose of 0.5 mg/0.05 ml. The biosimilar is indicated for multiple retinal conditions, including neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, macular oedema secondary to retinal vein occlusion, and choroidal neovascularization. These conditions are among the leading causes of vision loss in adults and often require repeated intravitreal injections, making affordability and access key considerations for healthcare systems.
In addition to the vial presentation, BYOOVIZ is set to expand its available formulations in Europe. In November 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion for a pre-filled syringe presentation of BYOOVIZ. This formulation is expected to become available on the European market in the second quarter of 2026 and could offer added convenience for ophthalmologists by reducing preparation time and the risk of dosing errors.
Samsung Bioepis emphasized that its direct commercialization approach is designed to strengthen relationships with healthcare providers and payers, while improving patient access to high-quality biosimilar medicines. As European healthcare systems continue to encourage the adoption of biosimilars to manage costs and expand treatment options, the company sees BYOOVIZ as a key product in its growing ophthalmology portfolio.