The FDA recorded a supplement on 28 August to biologics licence 761216 for Yusimry (adalimumab-aqvh). The record gives no detail of what changed. Biosimilar supplements usually cover manufacturing, presentation or labelling.
Nothing in the record indicates a new safety concern or a change to indications. Adalimumab biosimilars are widely used in India, but whether this product or change affects the Indian market is not known.
- No change to prescribing or monitoring follows from this record.
- Continue TB and hepatitis B screening before any adalimumab product.
- Record the brand and batch when patients switch between biosimilars.
Why it matters
It confirms that nothing in this record changes how adalimumab is prescribed.
Don't overread it
A licence supplement is not a new indication or a safety warning.
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