The FDA Drugs@FDA record shows an action dated 22 October on BLA 761298, PAVBLU (aflibercept-ayyh), held by Amgen. The four-letter suffix marks it as a biosimilar of aflibercept.
The record does not state what the action covers — a new approval, a supplement or a labelling change — so its clinical significance cannot be judged from this entry alone.
Whether this product is available in India, or what CDSCO has said about it, is not stated in the record.
- The record lists an FDA action on 22 October for aflibercept-ayyh (PAVBLU).
- It is a biosimilar of aflibercept, used for neovascular AMD and diabetic macular oedema.
- The record does not say what the action covers.
- Check the current label before assuming any new indication or dosing change.
Why it matters
Biosimilar label changes affect substitution and access decisions for anti-VEGF services.
Don't overread it
A database entry without detail is not evidence of a new indication.
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