FDA's database lists a supplement dated 25 September to the biologics licence application for adalimumab-aqvh, an adalimumab biosimilar. The listing does not say what the supplement covers; supplements can concern manufacturing, labelling, presentations or interchangeability.
There is nothing for prescribers to act on until the label change is published. The notice concerns the US licence only.
- Treat this as an administrative listing until the updated label is published.
- Check the current label before switching patients between adalimumab products.
- Continue standard monitoring for patients on any adalimumab product.
Why it matters
Biosimilar supplements can change device presentations or interchangeability status, which affects switching.
Don't overread it
A licence supplement is not a new indication or a safety finding.
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