Key Takeaways

  • Byooviz, the first FDA-approved ophthalmic biosimilar in the United States, has been relaunched through a new commercialization partnership between Samsung Bioepis and Harrow
  • Harrow is responsible for US commercialization of Byooviz and Opuviz, while Samsung Bioepis continues to oversee development, manufacturing, and regulatory activities
  • The relaunch is intended to expand access to lower-cost anti-VEGF treatment options for retinal diseases

Samsung Bioepis has announced the relaunch of Byooviz (ranibizumab-nuna) in the United States through its new commercialization partnership with Harrow, marking the return of the ophthalmic biosimilar to the US market following the transition of commercialization rights from Biogen.

Under an agreement announced in July 2025, Harrow assumed responsibility for commercialization of Byooviz, a biosimilar referencing Lucentis (ranibizumab), and Opuviz (aflibercept-yszy), a biosimilar referencing Eylea (aflibercept), after commercialization rights fully transitioned back to Samsung Bioepis by the end of 2025. Samsung Bioepis retains responsibility for product development, manufacturing, and regulatory activities.

Byooviz was approved by the FDA in September 2021 as the first ophthalmic biosimilar authorized in the United States. The product is indicated for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization. The FDA granted the biosimilar interchangeable status in October 2023.

FDA-approved biosimilars are required to demonstrate no clinically meaningful differences from their reference biologics in terms of safety, purity, and potency.

"Today marks an exciting new chapter for Byooviz in the US. As the first FDA-approved biosimilar to Lucentis, Byooviz has already demonstrated its value in expanding access to critical retinal disease treatments," said Linda Choi MacDonald, executive vice president and global head of commercial at Samsung Bioepis, in a company statement. "With Harrow now leading commercialization efforts, we are reigniting our commitment to ensuring patients and retina specialists across America have access to this quality-proven, safe and effective biosimilar option. We believe this relaunch will ultimately help more patients with critical ophthalmic diseases receive the vision-saving treatments they need."

Outside the United States, Byooviz received approval from the European Commission and the United Kingdom in August 2021 and was approved in Canada in March 2022. Samsung Bioepis directly commercializes the product in Europe.