On 2 September 2026 the FDA's Drugs@FDA database recorded a supplement to biologics licence application 761498 for tocilizumab-anoh (Avtozma), Celltrion's biosimilar to tocilizumab.
The record does not state what the supplement changed. Biosimilar supplements often add presentations, align labelling with the reference product or change manufacturing. Nothing in the notice signals a new safety issue.
Its regulatory status in India is not stated in the record.
- No change to tocilizumab prescribing follows from this notice.
- Continue screening for tuberculosis and hepatitis B before starting tocilizumab or a biosimilar.
- Monitor liver enzymes, neutrophils and lipids as with the reference product.
- Record the product name and batch when using a biosimilar, for traceability.
Why it matters
Biosimilar licences are widening, which matters for access to IL-6 blockade where cost limits use.
Don't overread it
A licence supplement is not a new indication or a safety warning.
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