The FDA recorded a supplemental approval on 25 September 2026 for Yusimry (adalimumab-aqvh, BLA 761216), an adalimumab biosimilar listed under Emerge Bioscience.
The record does not state what the supplement covers. Biosimilar supplements commonly concern manufacturing, presentation, labelling or interchangeability status rather than new indications. Without the label text, no change in clinical use can be inferred.
For gastroenterologists using adalimumab in inflammatory bowel disease, nothing changes in dosing, monitoring or infection screening. Whether this product is available in India is not stated.
- No change to adalimumab prescribing in IBD follows from this supplement.
- Check the updated label before assuming any change in interchangeability or presentation.
- Continue TB and hepatitis B screening before starting any adalimumab product.
- Record the specific product and batch when switching between adalimumab biosimilars.
Why it matters
Biosimilar switching is common in IBD clinics, and label changes can affect which product pharmacies supply.
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A licence supplement is not a new indication or a safety finding.
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