FDA's Drugs@FDA database recorded a supplement dated 25 September to the biologics licence (BLA761216) for adalimumab-aqvh, held by Emerge Bioscience. The record does not state the content of the supplement.
Supplements to biosimilar licences commonly cover manufacturing, presentation or labelling changes. Nothing in the record indicates a new safety concern or new indication, and it does not change how adalimumab should be prescribed or monitored.
Several adalimumab biosimilars are marketed in India; whether this product is among them, and CDSCO's position on it, is not stated.
- Make no change to adalimumab prescribing on the strength of this record.
- Continue standard tuberculosis and hepatitis B screening before any TNF inhibitor.
- Record the specific biosimilar product on the prescription for pharmacovigilance.
- Look to FDA safety communications, not supplements, for new adalimumab warnings.
Why it matters
It is a reminder that most regulatory activity is housekeeping rather than new safety information.
Don't overread it
A licence supplement is not a new indication or a safety finding.
Read the rest in the app
You have read your two free briefings this month. The app carries all 27 specialties, every morning, free — and this finding is waiting in it.
Scan to keep reading on your phone. No account needed to start.
Tomorrow morning, before your first patient
One edition a day for rheumatology, written by the desk, every claim tied to its paper. Six minutes.
Get the app — free