“This is a significant milestone for Samsung Bioepis as the company continues to strengthen its presence in Europe by expanding its portfolio of directly commercialized products. Leveraging the past three years of experience with EPYSQLI (eculizumab) and the newly launched OBODENCE (denosumab) and XBRYK (denosumab) in Europe, we will continue on our journey to become a fully integrated biopharmaceutical company with end-to-end capabilities from development to commercialization,” said Antonio Rito, Vice President and Head of Europe, at Samsung Bioepis. “We will work closely with payers and healthcare professionals to ensure seamless access to our biosimilar medicines for patients in need.”

BYOOVIZ was first approved by the European Commission (EC) in August 2021 as a single use vial for intravitreal use (0.5 mg/0.05 ml) for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization (CNV). In November 2025, European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for BYOOVIZ pre-filled syringe (PFS). The PFS presentation is expected to be available on the European market starting in the second quarter of 2026.