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.