Samsung Bioepis Takes Direct Control of BYOOVIZ, Shaking Up EU Eye Care Market

INCHEON, Korea – January 02, 2026 – Samsung Bioepis has officially begun the direct commercialization of its ranibizumab biosimilar, BYOOVIZ®, across multiple European countries. The strategic move, which sees the company assume full commercial rights from its former partner Biogen, marks a significant step in its ambition to become a fully integrated biopharmaceutical force in Europe and is poised to intensify competition in the lucrative market for sight-saving ophthalmic therapies.

BYOOVIZ®, a biosimilar to the reference product Lucentis® (ranibizumab), was the first ophthalmology biosimilar to gain approval from the European Commission in August 2021. It is indicated for treating a range of serious retinal conditions, including neovascular (wet) age-related macular degeneration (AMD), diabetic macular oedema (DME), and retinal vein occlusion (RVO). The transition to a direct sales model, effective January 2026, places Samsung Bioepis at the forefront of marketing, sales, and distribution for the product.

A Strategic Pivot Towards Full Integration

This initiative is the latest and most prominent step in Samsung Bioepis’s deliberate evolution from a development-focused company to a vertically integrated biopharmaceutical player with end-to-end capabilities. The company has been methodically building its commercial infrastructure in Europe since 2023, a market seen as more accessible for direct entry due to its country-level public tender systems, compared to the fragmented, private insurance-driven landscape of the United States.

This direct commercialization of BYOOVIZ® follows the successful launch of other products under the company's own banner. These include the rare disease treatment EPYSQLI® (eculizumab biosimilar) and the osteoporosis therapies OBODENCE® and XBRYK® (denosumab biosimilars). With BYOOVIZ®, Samsung Bioepis now directly manages a portfolio of four products in Europe, reinforcing its market presence and operational autonomy.

“This is a significant milestone for Samsung Bioepis as the company continues to strengthen its presence in Europe by expanding its portfolio of directly commercialized products,” said Antonio Rito, Vice President and Head of Europe at Samsung Bioepis, in a recent statement. “We will work closely with payers and healthcare professionals to ensure seamless access to our biosimilar medicines for patients in need.”

By taking direct control, the company aims to forge stronger relationships with healthcare providers and national payers, allowing for more agile management of product supply and pricing strategies tailored to individual European markets.

Reshaping the Ophthalmic Treatment Landscape

The European ranibizumab market is becoming an increasingly competitive arena. While the originator, Lucentis, has long dominated, the entry of multiple biosimilars is fundamentally altering the dynamics. Alongside BYOOVIZ®, other approved ranibizumab biosimilars vying for market share include Formycon's Ranivisio (marketed by Teva), STADA and Xbrane's Ximluci, and another biosimilar from Lupin commercialized by Sandoz.

This influx of competition is a powerful driver of cost reduction for national health systems. Historically, the introduction of biosimilars leads to price drops of 15-30% versus the originator product, and in some cases, confidential rebates can drive savings significantly higher. According to market data from IQVIA, biosimilars have already generated a staggering €56 billion in cumulative savings for European healthcare systems, demonstrating their profound economic impact.

Samsung Bioepis’s direct entry with BYOOVIZ® is expected to accelerate this trend. By eliminating a commercial partner, the company gains more flexibility in its pricing and tendering strategies, which could lead to more aggressive competition and, ultimately, greater cost-effectiveness for healthcare providers. This financial relief allows health systems to reallocate resources and expand patient access to these critical treatments for chronic, vision-threatening diseases.

Enhancing Patient Care and Clinical Practice

Beyond market economics, the evolution of BYOOVIZ® promises tangible benefits for both patients and clinicians. A key development is the anticipated launch of a pre-filled syringe (PFS) presentation of the treatment in the second quarter of 2026. This follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in November 2025.

The PFS format is widely considered the standard of care in modern ophthalmology for intravitreal injections. Its advantages over traditional vial-and-syringe preparation are substantial. Clinical studies have shown that using a pre-filled syringe can reduce preparation time by as much as 39%, streamlining clinic workflows and allowing ophthalmologists to treat more patients efficiently.

More importantly, the PFS enhances safety. The simplified, ready-to-use format minimizes the risk of preparation errors and contamination, which can lead to serious complications like endophthalmitis, a severe eye infection. The design also helps reduce the incidence of intraocular air bubbles and silicone oil droplets, while ensuring a more precise and consistent administered dose. For retina specialists, these advantages translate to a safer, faster, and more reliable treatment administration process, improving the overall standard of care for patients with debilitating retinal conditions.

Shifting Alliances in the Biosimilar Space

The transition of BYOOVIZ® commercial rights stems from an Asset Purchase Agreement between Samsung Bioepis and Biogen finalized in October 2025. While this marks the end of Biogen's commercial involvement with this specific product in Europe, it does not signal an exit from the biosimilar sector for the American biotech giant.

In fact, after a comprehensive strategic review in 2024, Biogen's leadership decided to retain its broader biosimilar business, deeming it a valuable asset for its shareholders. The company's biosimilar franchise continues to generate significant revenue, and it remains an active part of its portfolio. The decision to return the European rights for BYOOVIZ® and another ophthalmology biosimilar, OPUVIZ®, appears to be a strategic realignment, allowing Biogen to concentrate its resources on high-priority therapeutic areas, most notably its burgeoning Alzheimer's disease franchise, which includes the recently approved treatment LEQEMBI. This move illustrates the dynamic and evolving nature of partnerships within the pharmaceutical industry, where companies continually reassess their portfolios to maximize value and focus on core strengths.