June 1, 2026 - Samsung Bioepis today announced the commercial launch of OPUVIZ (aflibercept 40 mg/mL solution for injection), a biosimilar referencing Regeneron and Bayer's Eylea, across Europe. This marks the fifth biosimilar product directly commercialized by Samsung Bioepis on the continent and represents a major escalation in competition for the anti-VEGF ophthalmology market, which generates over $10 billion in annual global sales.
The European rollout follows a settlement and license agreement announced in January 2026 between Samsung Bioepis, Regeneron, and Bayer, clearing the path for commercialization in Europe and the Rest of the World. European Commission approval was secured in November 2024, and a positive CHMP opinion for the 40 mg/mL pre-filled syringe formulation followed in November 2025, with that formulation expected to launch in Q3 2026.
Aflibercept is a recombinant fusion protein that binds vascular endothelial growth factor (VEGF-A), VEGF-B, and placental growth factor (PlGF), inhibiting angiogenesis in the eye. Eylea, the originator, is one of the world's best-selling drugs, approved for wet age-related macular degeneration (AMD), diabetic macular edema (DME), and other retinal conditions.
The global anti-VEGF market exceeds $10 billion annually, driven by rising prevalence of diabetic retinopathy and AMD in aging populations. With original Eylea patents facing challenges and multiple biosimilar entrants now approved worldwide, the market is entering a period of rapid price erosion and volume expansion.
For API suppliers, the implications are significant. Aflibercept is a complex biologic produced in CHO cell expression systems. Each biosimilar entrant requires dedicated manufacturing capacity, quality systems, and supply chain infrastructure, multiplying demand across the entire biologics value chain.
OPUVIZ is part of an aggressive 2026 commercialization push by Samsung Bioepis in Europe:
The company also launched a ustekinumab biosimilar referencing Stelara in Japan during May 2026. This cadence positions Samsung Bioepis among the most active biosimilar developers globally, rivaling Sandoz, Amgen, and Biocon in pipeline breadth and launch velocity.
Aflibercept biosimilar manufacturing creates specific opportunities across the biologics value chain:
The molecule itself - a 115 kDa fusion protein of VEGF receptor extracellular domains fused to IgG1 Fc - requires precise post-translational modifications including glycosylation and disulfide bond formation, creating barriers that favor established, quality-focused suppliers.
Samsung Bioepis faces competition from multiple aflibercept biosimilar developers including Formycon/Coherus (Cimerli), Alvotech, and Celltrion. The crowded field is expected to drive aflibercept prices down 30-50% within two years of biosimilar availability, dramatically improving patient access.
For API manufacturers, volume growth is expected to more than offset price declines, creating a net positive demand signal. Samsung Bioepis' strategy - three directly commercialized biosimilars launched in Europe within six months - signals the company is building scale to compete on both price and market access. For suppliers aligned with this trajectory, the commercial opportunity is substantial and growing.
