FDA Approves Samsung Bioepis’ Byooviz Biosimilar to Lucentis

Samsung Bioepis has announced that the FDA has granted approval for the supplemental biologics license application (BLA) of Byooviz (ranibizumab-nuna) as a biosimilar product that can be interchanged with Lucentis (ranibizumab).

Originally approved by the FDA in September 2021, Byooviz marked a significant milestone as the first ophthalmology biosimilar in the United States for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (CNV). This recent FDA approval now designates Byooviz as interchangeable for all these approved indications.

In order to demonstrate interchangeability, the FDA requires that the data provided in the application demonstrate that the risk in terms of safety or reduced effectiveness when alternating or switching between the use of Byooviz and its reference product is not greater than the risk associated with using the reference product alone. As an interchangeable biosimilar, Byooviz is expected to offer the same level of safety and efficacy as Lucentis when used as a substitute.

Biogen has been responsible for the commercialization of Byooviz in the United States since June 2022. In November 2019, Samsung Bioepis and Biogen entered into an exclusive commercialization agreement covering two ophthalmology biosimilar candidates, SB11/Byooviz (ranibizumab) and SB15 (aflibercept), in various global markets.