Opuviz aflibercept biosimilar debuts in Europe for retinal disease treatment

Samsung Bioepis has launched aflibercept (Opuviz; Samsung Bioepis) 40 mg/mL solution for injection in a vial across Europe as a biosimilar referencing aflibercept (Eylea; Regeneron), adding another anti–vascular endothelial growth factor (VEGF) option for retinal diseases treated with intravitreal therapy.¹

“We are pleased to launch Opuviz in Europe, marking a significant milestone in expanding patient access to ophthalmology treatments,” Antonio Rito, vice president and head of Europe at Samsung Bioepis, said in the company announcement.¹

The launch follows European Commission approval of the aflibercept biosimilar in November 2024 and Medicines and Healthcare products Regulatory Agency approval in April 2025, according to the company. The product is indicated for adults with neovascular age-related macular degeneration (wet AMD), visual impairment due to macular edema secondary to branch or central retinal vein occlusion, diabetic macular edema (DME), and visual impairment due to myopic choroidal neovascularization.¹

Opuviz is a recombinant fusion protein that inhibits VEGF signaling, thereby reducing pathologic neovascularization and vascular leakage in the retina and choroid.¹ The reference product, Eylea, has been a major component of anti-VEGF treatment for wet AMD and DME, supported by randomized trials showing visual outcomes comparable with monthly ranibizumab in wet AMD and superiority over laser in DME.^3,4

The current update is commercial rather than a new efficacy readout. Samsung Bioepis did not report new clinical trial results, numerical biosimilarity margins, or study-level efficacy outcomes in the launch announcement. The company stated that the safety of Opuviz had been evaluated and that adverse effects were considered comparable with those of Eylea.¹ The European Medicines Agency’s biosimilar approval framework generally relies on the totality of evidence, including analytical comparability and clinical data sufficient to demonstrate no clinically meaningful differences from the reference medicine.²

The company listed the most common adverse events associated with Opuviz as conjunctival hemorrhage, retinal haemorrhage, reduced vision, and eye pain. Other common events include vitreous detachment, cataract, vitreous floaters, and increased intraocular pressure. Serious injection-related risks include blindness, endophthalmitis, cataract, increased intraocular pressure, vitreous haemorrhage, and vitreous or retinal detachment.¹ Opuviz is contraindicated in patients with known or suspected ocular or periocular infection and in those with severe intraocular inflammation.¹

Clinical context for retina specialists

For retina specialists, the introduction of another aflibercept biosimilar in Europe may be most relevant to access, procurement, and payer policy rather than to immediate changes in clinical decision-making. Anti-VEGF therapy remains the standard treatment approach for wet AMD, DME, retinal vein occlusion–associated macular edema, and myopic choroidal neovascularization, but frequent intravitreal injections continue to create treatment burden for patients, caregivers, clinics, and health systems.

In wet AMD, aflibercept’s pivotal VIEW 1 (00509795) and VIEW 2 (00637377) trials showed that intravitreal aflibercept regimens maintained vision at week 52 and were clinically comparable with monthly ranibizumab, including an every-8-week aflibercept regimen after initial monthly dosing.³ In DME, the VIVID (01331681) and VISTA (01363440) trials demonstrated that intravitreal aflibercept produced greater mean visual acuity gains than macular laser photocoagulation through 52 weeks.⁴ These studies established the clinical role of the reference molecule, but they do not by themselves determine interchangeability policies or switching practices for individual biosimilars, which vary by jurisdiction and local regulation.

Opuviz is the fifth biosimilar product to be directly commercialized by Samsung Bioepis, according to the announcement. The company also noted that Opuviz is available in the Republic of Korea under the brand name Afilivu.¹ In January 2026, Samsung Bioepis announced a settlement and license agreement with Regeneron and Bayer concerning commercialization of its biosimilar to Eylea 2 mg in Europe and the rest of the world.¹

A prefilled syringe presentation of Opuviz 40 mg/mL received a positive opinion from the Committee for Medicinal Products for Human Use in November 2025 for the same indications as the vial formulation, according to the company.¹ Availability, substitution rules, and prescribing information may differ by country, making local product labeling and institutional policy important considerations for clinicians.

References
1. Samsung Bioepis launches Opuviz (aflibercept) 40 mg/mL vial across Europe, to treat ophthalmic conditions. Business Wire. May 29, 2026. Accessed May 29, 2026. https://www.businesswire.com/news/home/20260528005232/en/Samsung-Bioepis-Launches-Opuviz-Aflibercept-40-mgmL-Vial-Across-Europe-to-Treat-Ophthalmic-Conditions
2. European Medicines Agency. Opuviz: European public assessment report. Published 2024.
3. Heier JS, Brown DM, Chong V, et al. Intravitreal aflibercept for wet age-related macular degeneration. Ophthalmology. 2012;119(12):2537-2548. doi:10.1016/j.ophtha.2012.09.006
4. Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept for diabetic macular edema. Ophthalmology. 2014;121(11):2247-2254. doi:10.1016/j.ophtha.2014.05.006