The FDA Drugs@FDA database lists a supplement to biologics licence application 761216 for YUSIMRY (adalimumab-aqvh), an adalimumab biosimilar, dated 28 August 2026. The applicant listed is Emerge Bioscience Pte Ltd.
The record does not say what the supplement covers. Biosimilar supplements often concern manufacturing, labelling, presentation or interchangeability rather than new clinical data, but that cannot be confirmed from this entry.
Adalimumab is widely used for Crohn's disease and ulcerative colitis, and several adalimumab biosimilars are marketed in India under CDSCO approval. Whether this product is available in India is not established. No change to prescribing follows from this record alone.
- Note the supplement if your service uses YUSIMRY in the US
- Check the updated label for the specific change before acting
- Continue current adalimumab biosimilar prescribing in IBD unchanged
- Report any switching-related loss of response through pharmacovigilance
Why it matters
Licence supplements to biosimilars can change presentation, labelling or interchangeability status.
Don't overread it
A licence supplement is not a new indication, and this record does not describe what changed.
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