FDA's database lists a supplement to BLA 761216, the adalimumab biosimilar adalimumab-aqvh marketed as Yusimry, dated 28 August. The record does not state what the supplement covers.
Biosimilar supplements often concern labelling, presentation or manufacturing. Nothing here changes prescribing for inflammatory bowel disease until the revised label is published. Its status in India is not stated.
- No change to adalimumab prescribing follows from this listing.
- Record the specific product at each prescription for pharmacovigilance.
- Check the FDA label when the revised version is posted.
Why it matters
Adalimumab biosimilars are central to affordable IBD care, so their labels are worth tracking.
Don't overread it
A licence supplement is not a new indication or a safety finding.
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