Samsung Bioepis launches Opuviz, an Eylea biosimilar, in Europe
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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)
Samsung Bioepis said it has launched Opuviz, its biosimilar to Eylea, across Europe starting May 29, 2026, marking the commercial debut of another aflibercept challenger in a high-value ophthalmology market. The launch covers Opuviz 40 mg/mL solution for injection in a vial, and comes about 18 months after European Commission approval on November 13, 2024. (sttinfo.fi)
The background here is a longer buildout in ophthalmology biosimilars. Samsung Bioepis and Biogen had previously partnered on ophthalmology biosimilars in multiple markets, but Samsung Bioepis has been shifting toward more direct commercialization in Europe. In January 2026, Samsung Bioepis also announced a settlement and license agreement with Regeneron and Bayer tied to commercialization of its aflibercept biosimilar in Europe and the rest of the world, helping clear the way for launch timing now being executed. (investors.biogen.com)
Regulators had already laid the scientific groundwork. EMA says Opuviz is highly similar to Eylea in structure, purity, biological activity, and pharmacokinetics, and cited a study in 449 patients with wet AMD showing roughly seven letters of visual acuity improvement at eight weeks in both the Opuviz and Eylea groups. EMA also said the side-effect profile was comparable to the reference product, with common adverse events including conjunctival haemorrhage, retinal haemorrhage, reduced vision, and eye pain, while serious injection-related risks include endophthalmitis, retinal detachment, and blindness. (ema.europa.eu)
Samsung Bioepis framed the launch as part of a broader European biosimilar push. In its announcement, the company said Opuviz is its fifth biosimilar to be directly commercialized in Europe, alongside recent milestones for Byooviz and Xbryk. The company also noted that Opuviz is already marketed in South Korea under the brand name Afilivu, and that a pre-filled syringe presentation later received a positive CHMP opinion in November 2025 for the same indications as the vial. (sttinfo.fi)
Industry reaction suggests this launch is less about a single product and more about the next phase of anti-VEGF competition. Ophthalmology Times wrote in February 2026 that defined launch dates for aflibercept biosimilars could influence procurement strategies and payer policies, especially given the central role of anti-VEGF therapy in wet AMD, diabetic macular oedema, diabetic retinopathy, and retinal vein occlusion. IQVIA likewise said in a February 2026 report that ophthalmology had recently seen aflibercept biosimilar entry, reinforcing the sense that this is now a live commercial category, not just a regulatory story. (ophthalmologytimes.com)
That competitive field is getting crowded. Other aflibercept biosimilars, including Yesafili and Ahzantive, are already authorized in the EU, and Formycon said this month that Ahzantive and Baiama had become available in key European markets. In practical terms, that means Opuviz is entering a market where access and uptake will likely be shaped not only by clinical familiarity, but also by national reimbursement systems, tenders, contracting, and presentation format. That’s especially important in ophthalmology, where administration logistics and clinic workflow can influence product choice alongside price. (ema.europa.eu)
Why it matters: For veterinary professionals, this is mainly a market-structure story rather than a direct practice-change event. Opuviz is a human medicine, but the launch illustrates how biosimilars are continuing to move into specialized biologic categories that depend on trust in comparability data, strong pharmacovigilance, and payer acceptance. Those same forces increasingly shape expectations around biologics in animal health, especially as pet parents, clinics, and payers put more pressure on affordability without giving up clinical confidence. (ema.europa.eu)
What to watch: The next signals will be local launch sequencing across Europe, pricing and tender outcomes, and whether Samsung Bioepis secures broader uptake with the pre-filled syringe presentation if it reaches market. It’s also worth watching how aflibercept biosimilar competition interacts with branded lifecycle strategies, including higher-dose formulations and contracting tactics designed to defend share. (sttinfo.fi)