Samsung Bioepis gets label supplement approved for Byooviz ranibizumab biosimilar
FDA approved a labeling supplement for Byooviz, Samsung Bioepis's ranibizumab biosimilar injection.
This week's only update for Samsung Bioepis involves a labeling change to its approved biosimilar product.
- The FDA approved supplement 20 for BYOOVIZ (ranibizumab-nuna), a 0.5mg injectable product sponsored by Samsung Bioepis Co Ltd1. The submission was classified as Labeling and given standard review priority, with a submission status date of 2026-09-01.
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