INCHEON, South Korea, May 29, 2026
Samsung Bioepis Co., Ltd. has announced the European launch of OPUVIZ™ (aflibercept) 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea®, marking another significant milestone in the company’s rapidly expanding ophthalmology portfolio. The launch strengthens Samsung Bioepis’ position in the European biosimilars market and represents the company’s fifth biosimilar product to be directly commercialized in Europe. As healthcare systems across the continent continue to seek cost-effective biologic alternatives, the introduction of OPUVIZ is expected to improve patient access to advanced ophthalmic treatments for several serious vision-threatening conditions. The commercialization also follows the company’s recent direct launch of BYOOVIZ™ (ranibizumab) and reflects Samsung Bioepis’ growing commitment to expanding access to high-quality biosimilar medicines across multiple therapeutic areas.
OPUVIZ Expands Access to Proven Ophthalmology Treatments
OPUVIZ contains aflibercept, a vascular endothelial growth factor (VEGF) inhibitor designed to block abnormal blood vessel growth and leakage within the eye. The biosimilar is approved for the treatment of several major retinal diseases, including neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), and myopic choroidal neovascularization (myopic CNV).
These conditions are among the leading causes of vision loss worldwide, creating substantial healthcare and socioeconomic burdens. By introducing a biosimilar alternative to aflibercept, Samsung Bioepis aims to support broader patient access while helping healthcare providers and payers manage treatment costs more effectively. The company emphasized that OPUVIZ has demonstrated comparable safety, efficacy, and quality to the reference product, reinforcing confidence among physicians and patients seeking reliable biologic treatment options.
Strategic Growth Strengthens Samsung Bioepis’ Biosimilar Portfolio
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The OPUVIZ launch represents another important achievement in Samsung Bioepis’ European commercialization strategy. Earlier in 2026, the company began direct commercialization of BYOOVIZ™, a biosimilar referencing Lucentis®, and also launched XBRYK™ (denosumab) in Europe. Together, these products highlight the company’s expanding capabilities in bringing complex biosimilars directly to market.
Samsung Bioepis also announced earlier this year that it had reached a settlement and licensing agreement with Regeneron and Bayer regarding commercialization rights for its aflibercept biosimilar in Europe and other international territories. This agreement helped pave the way for the current launch and further strengthens the company’s long-term growth strategy within ophthalmology. As biosimilars continue to play an increasingly important role in healthcare sustainability, Samsung Bioepis is positioning itself as a key global supplier of affordable biologic therapies.
Future Expansion Includes Pre-Filled Syringe Presentation
Looking ahead, Samsung Bioepis is preparing for the launch of OPUVIZ 40 mg/mL pre-filled syringe, which previously received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The company expects this presentation to become commercially available during the third quarter of 2026, providing healthcare professionals with an additional administration option designed to improve convenience and workflow efficiency.
Company executives noted that direct commercialization capabilities now enable closer collaboration with healthcare providers, hospitals, and reimbursement organizations throughout Europe. With growing demand for ophthalmic biologics and increasing pressure on healthcare budgets, biosimilars such as OPUVIZ are expected to play a crucial role in expanding treatment availability while maintaining high standards of quality and patient care.
The latest launch further reinforces Samsung Bioepis’ mission to make advanced biologic medicines more accessible to patients worldwide and highlights the continuing evolution of the global biosimilar market.
Source: Samsung Bioepis press release
