OPUVIZ Europe Launch Puts Samsung Bioepis in Retina Fight

The OPUVIZ aflibercept biosimilar launch in Europe began on May 29, 2026, with Samsung Bioepis rolling out a 40 mg/mL vial referencing Eylea for adults with wet age-related macular degeneration, diabetic macular oedema, retinal vein occlusion and myopic choroidal neovascularisation. The Korean biosimilar developer announced the rollout in Samsung Bioepis’s launch notice for OPUVIZ in Europe, making the product its fifth biosimilar directly commercialized by the company in the region.

For Samsung Bioepis, this launch tests whether moving closer to doctors, payers and hospital buyers can matter as much as winning regulatory clearance. The science cleared the European Medicines Agency in 2024; the harder work now sits in procurement rooms, retina clinics and country reimbursement talks.

The Launch That Turns a License Into a Sales Test

OPUVIZ reaches Europe after a January patent settlement and license agreement with Regeneron Pharmaceuticals, the U.S. drugmaker behind Eylea, and Bayer, its ex-U.S. commercial partner. That agreement cleared Samsung Bioepis to sell its 2 mg aflibercept biosimilar outside the United States and Canada on a staged timetable, with Europe following the United Kingdom.

We are pleased to launch OPUVIZ in Europe, marking a significant milestone in expanding patient access to ophthalmology treatments,

said Antonio Rito, vice president and head of Europe at Samsung Bioepis, in the company statement.

The milestone language is standard launch copy. The business point is sharper. Samsung Bioepis now has a fifth directly commercialized biosimilar in Europe, after EPYSQLI, OBODENCE, XBRYK and BYOOVIZ. In January, it also began direct commercialization of BYOOVIZ, a ranibizumab biosimilar referencing Lucentis, and launched XBRYK, a denosumab vial. OPUVIZ adds a second eye-care asset to that direct European push.

OPUVIZ and Eylea Share the Same Regulatory Lane

The European Medicines Agency (EMA, the EU medicines regulator) lists OPUVIZ as an authorised biosimilar medicine, meaning it is highly similar to its reference medicine, Eylea, in structure, biological activity, safety and efficacy. The EMA’s OPUVIZ authorisation file says the product contains aflibercept and is used by intravitreal injection, an injection into the jelly-like fluid inside the eye.

For the vial presentation, the important dosing number is 2 mg aflibercept in 0.05 mL. The product information says 1 mL contains 40 mg aflibercept, and one vial includes more than the final injected dose so the physician can prepare the syringe and discard excess volume before injection.

The authorised adult indications cover four major retinal conditions:

• Neovascular wet age-related macular degeneration (AMD, damage to central vision caused by abnormal blood vessels under the macula).
• Visual impairment due to macular oedema after retinal vein occlusion (RVO, blockage of a vein carrying blood from the retina).
• Visual impairment due to diabetic macular oedema (DME, diabetes-related swelling in the macula).
• Visual impairment due to myopic choroidal neovascularisation, a complication linked to severe short-sightedness.

The active ingredient works by blocking vascular endothelial growth factor A (VEGF-A, a protein that helps drive abnormal blood vessel growth and leakage) and placental growth factor. That mechanism is why aflibercept sits at the center of so much retina spending.

Europe Gets a Crowded Aflibercept Shelf

Samsung Bioepis is entering a market that is already filling with Eylea biosimilar rivals. Regeneron’s latest annual patent litigation disclosures show a series of settlement windows for aflibercept 2 mg biosimilars from Biocon Biologics, Celltrion, Alvotech and Samsung Bioepis, with several launches clustering in early and mid 2026. The same Regeneron patent settlement disclosures identify Samsung Bioepis as permitted to launch in the rest of Europe in April 2026 and other covered jurisdictions in May.

Formycon AG, a German biosimilar developer, said its partner Klinge Biopharma began launching Ahzantive and Baiama pre-filled syringes in Germany, France and Italy on May 15, with other Central and Eastern European countries to follow. That Formycon aflibercept launch notice matters because device format and national coverage can decide uptake as much as the molecule.

The Money Pressure Comes From Bayer’s Line Item

Bayer’s 2025 annual report shows why the biosimilar race matters. Eylea remained one of Bayer’s top pharmaceutical products, but sales fell to €3.110 billion in 2025 from €3.306 billion in 2024. Bayer cited lower prices, especially in Canada, the United Kingdom and Japan, plus competitive pressure. Its newer Eylea 8 mg format helped offset some pressure by offering extended treatment intervals.

• €3.110 billion – Bayer’s reported 2025 Eylea sales, down from €3.306 billion a year earlier.
• 5.9% – The reported full-year decline in Bayer’s Eylea sales in 2025.
• 26% – The share of overall Eylea sales that Bayer attributed to Eylea 8 mg for the full year.

Those figures from Bayer’s latest Eylea sales table explain the tension for payers. Biosimilars can create savings, but the originator is trying to move doctors and patients toward a higher-dose format with longer intervals between injections. Every national buyer now weighs price against appointment burden, device format, clinician comfort and patient stability.

Samsung Bioepis Is Taking Back the Customer Relationship

The less flashy part of this story began months before the launch. In October 2025, Samsung Bioepis said it had entered an asset purchase agreement with Biogen covering two ophthalmology assets in Europe: BYOOVIZ and OPUVIZ. Under that deal, Samsung Bioepis would take full responsibility for BYOOVIZ commercialization from January 2026, while OPUVIZ was part of the same European ophthalmology asset transfer.

That Biogen rights transfer announcement changed the operating model. A partner-led biosimilar can clear the regulator and still leave the developer one step away from payer negotiations. Direct commercialization brings the developer closer to tender design, hospital pharmacy discussions, retina specialist education and country-level launch sequencing.

For Samsung Bioepis, the product mix also becomes cleaner. BYOOVIZ gives it a ranibizumab eye drug. OPUVIZ gives it an aflibercept eye drug. AFILIVU, the same aflibercept biosimilar sold in South Korea, gives the company live-market experience at home. Europe now tests whether that portfolio can travel across very different reimbursement systems.

Clinics Will Decide the Pace Country by Country

A central EU authorization does not make a medicine appear in every clinic at once. National reimbursement decisions, local tenders, hospital formularies and physician switching policies still shape the pace. Retina care adds another layer, because many patients receive repeated injections and may be stable on an existing anti-VEGF medicine.

The vial launch gives Samsung Bioepis a legal and commercial starting point. The pre-filled syringe version has a positive opinion from the Committee for Medicinal Products for Human Use (CHMP, EMA’s human medicines committee) and is expected to be available in the third quarter of 2026, according to the company. That device step may matter in busy retina clinics, where preparation workflow and injection-room efficiency carry practical weight.

Adoption now turns on a few country-level gates:

• Tender rules that decide whether a biosimilar can win volume through public purchasing.
• Hospital formulary reviews that determine whether doctors can prescribe the new option easily.
• Switching protocols that set how stable patients are moved, if at all.
• Device preference once the pre-filled syringe reaches the market.

If OPUVIZ gains payer placement without unsettling physician confidence, Samsung Bioepis gets more than another European approval. If it stays stuck behind tender timing and device preference, the launch will read like a regulatory win that needed a slower commercial clock.

Frequently Asked Questions

What Is OPUVIZ?

OPUVIZ is Samsung Bioepis’s aflibercept biosimilar referencing Eylea. In Europe, the launched product is a 40 mg/mL solution for injection in a vial and is used only under prescription by a doctor experienced in injections into the eye.

Is OPUVIZ the Same as Eylea?

OPUVIZ is a biosimilar to Eylea, which means EU regulators found it highly similar to Eylea in the required quality, safety and efficacy measures. Biosimilars are biological medicines, so they are approved through a similarity standard rather than as simple chemical generics.

Which Eye Conditions Is OPUVIZ Authorised to Treat in the EU?

OPUVIZ is authorised for adults with wet age-related macular degeneration, visual impairment due to macular oedema after retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation.

How Is OPUVIZ Given?

OPUVIZ is given by intravitreal injection into the affected eye. The EMA product information says it must be administered by a qualified physician experienced in giving intravitreal injections.

When Will the Pre-Filled Syringe Version Be Available?

Samsung Bioepis says the pre-filled syringe version of OPUVIZ received a positive CHMP opinion in November 2025 and is expected to be available in Europe in the third quarter of 2026.

Does the European Launch Mean OPUVIZ Is Available in Every Country?

No; a centralized EU marketing authorization allows use across the European Union, while reimbursement, tender timing, formulary adoption and local prescribing practice can still vary by country.

Disclaimer: This article is for informational purposes only and does not provide medical advice. Eye injections and biosimilar switching involve individual medical risks and should be discussed with a qualified ophthalmology professional. Regulatory status, launch timing and figures are accurate as of June 1, 2026.