Samsung Bioepis settles Eylea biosimilar patent dispute, secures U.S. launch in 2027
Samsung Bioepis reached settlement agreements with Regeneron and Bayer for its aflibercept biosimilar OPUVIZ, enabling U.S. launch in January 2027 and staged international rollout beginning early 2026.
Samsung Bioepis has entered into settlement and license agreements with Regeneron—and separately with Regeneron and Bayer—clearing a path for commercialization of its aflibercept biosimilar across the United States, Europe, and other global markets. Under the US agreement, OPUVIZ (aflibercept-yszy), a biosimilar to Eylea (aflibercept) 2 mg, may launch in January 2027. Financial terms were not disclosed.
A separate ex-US settlement enables launch in the United Kingdom beginning January 2026, in the rest of Europe from April 2026, and in other settled markets (excluding Korea) from May 2026.
In the United States, aflibercept-yszy received Food and Drug Administration (FDA) approval in May 2024 as a biosimilar to Eylea (aflibercept) 2 mg (40 mg/mL). The newly announced settlement resolves patent litigation and permits commercial launch in January 2027.
Outside the United States, Samsung Bioepis' aflibercept biosimilar (SB15; aflibercept 40 mg/mL solution) was approved by the European Commission in November 2024 and by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in April 2025.
Aflibercept is a recombinant fusion protein that binds VEGF-A, VEGF-B, and placental growth factor, thereby inhibiting angiogenesis and vascular permeability. The reference product, Eylea, was first approved by the FDA in 2011 for nAMD and subsequently for DME, DR, and macular edema following RVO.
The pivotal VIEW 1 and VIEW 2 trials demonstrated that aflibercept 2 mg administered every 8 weeks after 3 monthly loading doses was noninferior to monthly ranibizumab in maintaining vision in nAMD.
Samsung Bioepis, founded in Feb. 2012, posted annual sales of 1.672 trillion won in 2025, achieving its best performance ever. The company currently supplies a total of 11 biosimilar products in Korea. Under Samsung Epis Holdings, an investment holding company established in Nov. last year, the company is expanding its biosimilar pipeline while also actively pursuing new drug development focused on antibody-drug conjugates (ADC).