Samsung Bioepis' OfubizTM (Aflibercept) Biosimilar Approved in Europe for Ophthalmic Diseases
核心洞察
Samsung Bioepis (搜索) secures European approval for OfubizTM (搜索), an aflibercept biosimilar, marking its second ophthalmic treatment following BiubizTM (搜索).
OfubizTM (搜索) targets vascular endothelial growth factors (搜索), inhibiting neovascularization in diseases like wet age-related macular degeneration (搜索).
The approval expands treatment options for patients with macular degeneration (搜索), a leading cause of visual impairment and blindness.
Samsung Bioepis (搜索) has received European approval for OfubizTM (搜索) (aflibercept), a biosimilar to Regeneron's Eylea, expanding its portfolio of ophthalmic disease treatments. This marks the company's second treatment in this area, following the approval of BiubizTM (搜索) (ranibizumab). The approval comes roughly two months after receiving a positive opinion from the European Medicines Agency (EMA)'s drug use advisory committee.
Targeting Neovascularization in Macular Degeneration
OfubizTM (搜索) is designed to treat eye diseases, including wet age-related macular degeneration (搜索) (AMD). The drug works by inhibiting neovascularization through binding to vascular endothelial growth factors (搜索) (VEGF). Eylea, the original drug, generates approximately 12 trillion won in annual global sales.
Macular degeneration (搜索), characterized by visual impairment due to aging and inflammation of the macula (nerve tissue in the center of the retina), can lead to blindness in severe cases. The introduction of OfubizTM (搜索) offers a more accessible treatment option for patients suffering from this debilitating condition.
Samsung Bioepis' Expanding Biosimilar Portfolio
This approval represents the ninth biosimilar licensed to Samsung Bioepis (搜索) in Europe. Jeong Byeong-in, head of the RA team at Samsung Bioepis, stated, "We are happy to be able to expand patients' treatment options. We will continue to strive to provide biopharmaceuticals in various fields."