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Alvotech Provides Update on FDA Facility Inspection for AVT02 and AVT04

Jan 19, 2024

Alvotech announced that its facility in Iceland received a form 483 from the FDA with only one observation.  The inspection started on 10 January 2024 and has concluded.  Alvotech said it will provide a response to the FDA in the coming days, and that the observation is “readily addressable”.  The company believes it is in a position to receive FDA approval for AVT02 (adalimumab, biosimilar to AbbVie’s Humira®) and AVT04 (ustekinumab, biosimilar to Janssen’s Stelara®) by their respective goal dates of 24 February 2024 and 16 April 2024.

The European Commission granted marketing authorisation for AVT04 under the brand name Uzpruvo® – the first EU-approved biosimilar to Stelara® – on 10 January 2024.