India Pharma Outlook Team | Monday, 10 August 2026
Samsung Bioepis has launched its aflibercept biosimilar OPUVIZ in both vial and pre-filled syringe formats, marking an entry to Europe’s eye drug market.
The eye drug market now sees increased competition following regulatory approval and a patent settlement with Regeneron and Bayer.
Samsung Bioepis has rolled out OPUVIZ across multiple European countries to treat retinal diseases such as wet age-related macular degeneration and diabetic macular edema.
This eye drug expansion strengthens biosimilar adoption while driving pricing pressure. The launch also marks Samsung Bioepis’ continued push to scale its ophthalmology portfolio and expand direct commercialization in Europe.
Samsung Bioepis has entered the eye drug market with OPUVIZ, a biosimilar referencing aflibercept. The company has introduced the drug in 40 mg/mL strength for intravitreal injection. The European Commission granted approval earlier, enabling commercial rollout. Samsung Bioepis has launched the product across key European markets, expanding access to anti-VEGF therapy. The drug market now includes another competitor to Eylea, a blockbuster therapy developed by Regeneron and Bayer.
“We are pleased to introduce the pre-filled syringe presentation of OPUVIZ to the European market, building on the momentum of our recent European launch of OPUVIZ vial earlier this year,” said Antonio Rito, Vice President and Head of Europe, Samsung Bioepis.
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Samsung Bioepis has differentiated its offering in the eye drug market by launching both vial and pre-filled syringe biosimilar formats. The pre-filled syringe format reduces preparation time and supports faster administration in clinical settings.
Ophthalmologists can deliver intravitreal injections with greater efficiency using this format. The market increasingly values delivery innovation, and Samsung Bioepis has aligned its strategy with this trend. The company has already commercialised multiple biosimilars in Europe, and OPUVIZ marks another step in its ophthalmology biosimilars expansion.
OPUVIZ addresses key therapeutic segments within the drug market, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). These conditions require repeated anti-VEGF therapy in Europe, creating sustained demand. The drug market continues to grow due to rising prevalence of diabetes and ageing populations across Europe. Samsung Bioepis has positioned OPUVIZ to improve treatment access and affordability in these high-demand segments.
Samsung Bioepis has entered the eye drug market after securing a settlement agreement with Regeneron and Bayer. The agreement resolved patent disputes related to aflibercept, clearing the path for biosimilar launch. This development has enabled timely market entry and intensified Eylea biosimilar competition. The market now reflects a broader trend where patent expiries accelerate biosimilar penetration across Europe.
The entry of OPUVIZ has increased pricing competition within the eye drug market. Biosimilars typically offer cost advantages compared to originator biologics, encouraging adoption among healthcare systems and payers.
European markets actively promote biosimilar uptake to control healthcare expenditure. Samsung Bioepis has strengthened its position by combining competitive pricing with product innovation. The eye drug market continues to evolve as multiple biosimilars compete for share in the anti-VEGF therapy segment.
