Samsung Bioepis' Byooviz approved as interchangeable with Lucentis

24 October 2023

The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Byooviz (ranibizumab-nuna) as a biosimilar product interchangeable with Lucentis (ranibizumab).

The sBLA was submitted by South Korea’s Samsung Bioepis. Lucentis is marketed by Swiss pharma majors Novartis (NOVN: VX) and Roche’s (ROG: SIX).

The FDA originally approved Byooviz in September 2021 as the first ophthalmology biosimilar in the USA, for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV) and this latest approval designates Byooviz as interchangeable across all of these approved indications.

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