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Regulatory · 03 of 05

FDA records a supplement for the adalimumab biosimilar adalimumab-aqvh

No change to adalimumab prescribing in IBD follows from this record.

The FDA biologics database lists a supplement dated 25 September 2026 to the licence for adalimumab-aqvh, a biosimilar marketed as Yusimry. The record gives the product and applicant but not the content of the change.

Nothing in the record indicates a safety finding.

  • The supplement relates to BLA 761216 for adalimumab-aqvh (Yusimry).
  • It was recorded on 25 September 2026.
  • Supplements can cover labelling, presentation or manufacturing changes.
  • Several adalimumab biosimilars are marketed in India; this US record does not affect them.

Why it matters

Biosimilar labels change often, including interchangeability and presentation, which can affect pharmacy substitution.

Don't overread it

A licence supplement is not a new indication, and the record does not say what changed.

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