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Samsung Bioepis' OfubizTM (Aflibercept) Biosimilar Approved in Europe for Ophthalmic Diseases

• Samsung Bioepis secures European approval for OfubizTM, an aflibercept biosimilar, marking its second ophthalmic treatment following BiubizTM. • OfubizTM targets vascular endothelial growth factors, inhibiting neovascularization in diseases like wet age-related macular degeneration. • The approval expands treatment options for patients with macular degeneration, a leading cause of visual impairment and blindness. • This marks the ninth biosimilar approval for Samsung Bioepis in Europe, reinforcing its commitment to providing diverse biopharmaceutical options.

Samsung Bioepis has received European approval for OfubizTM (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 (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 is designed to treat eye diseases, including wet age-related macular degeneration (AMD). The drug works by inhibiting neovascularization through binding to vascular endothelial growth factors (VEGF). Eylea, the original drug, generates approximately 12 trillion won in annual global sales.
Macular degeneration, 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 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 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."
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[1]
Samsung Bioepis has received product approval for its Eilean biosimilar "OfubizTM ...
mk.co.kr · Nov 19, 2024

Samsung Bioepis receives European approval for its second ophthalmic disease treatment, OfubizTM, following a positive E...

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