The FDA recorded a supplement dated 1 September 2026 to Samsung Bioepis's biologics licence application for Byooviz (ranibizumab-nuna, BLA 761202). The record does not state what the supplement changes.
Byooviz is a biosimilar to ranibizumab for neovascular age-related macular degeneration and related retinal conditions. Supplements to biosimilar licences are usually manufacturing, labelling or presentation changes. Nothing here indicates a new indication or safety concern. Whether this product or this change applies in India is not stated in the record.
- Treat this as an administrative licence change unless a label update is published.
- Continue current ranibizumab or biosimilar protocols unchanged.
- Record the product and batch given at each injection for pharmacovigilance.
- Check the Indian regulatory status of any specific biosimilar separately; it is not given here.
Why it matters
Biosimilar supply affects cost and access to anti-VEGF therapy.
Don't overread it
A licence supplement is not a new indication or a safety communication.
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