Samsung Bioepis launches Opuviz, an Eylea biosimilar, in Europe

Samsung Bioepis has launched Opuviz, its aflibercept biosimilar referencing Eylea, across Europe, with the company saying rollout starts May 29, 2026. The product is a 40 mg/mL intravitreal vial formulation for adults with wet age-related macular degeneration, diabetic macular oedema, macular oedema following retinal vein occlusion, and myopic choroidal neovascularisation. Opuviz was authorized by the European Commission on November 13, 2024, after EMA concluded it was highly similar to Eylea, with comparable efficacy and safety based in part on a 449-patient wet AMD study. Samsung Bioepis said the launch follows a January 2026 settlement and license agreement with Regeneron and Bayer covering commercialization in Europe and other ex-US markets. (sttinfo.fi)

Why it matters: This is another sign that aflibercept biosimilar competition is moving from regulatory approval into real commercial execution in Europe. For veterinary professionals, the direct clinical impact is limited because Opuviz is a human ophthalmology product, but the broader takeaway is more relevant: biosimilar competition continues to expand into specialized, procedure-heavy categories where administration, safety monitoring, and payer contracting all matter. That trend can affect how manufacturers, distributors, and health systems think about biologic access, pricing pressure, and formulary strategy across animal and human health markets. Europe’s biosimilar environment is already mature, and IQVIA said in early 2026 that ophthalmology had recently seen aflibercept biosimilar entry, underscoring how quickly this segment is evolving. (iqvia.com)

What to watch: Watch for country-by-country reimbursement decisions, tender wins, and whether Samsung Bioepis expands Opuviz beyond the vial presentation after the company said a pre-filled syringe version had received a positive CHMP opinion in November 2025. (sttinfo.fi)