Alvotech announced in its 2023 Q2 Earnings Presentation that it has resubmitted its interchangeable BLA for AVT02, biosimilar to AbbVie’s high concentration Humira® (adalimumab). The company did not disclose the BsUFA date but anticipated launch in 2024.
The FDA issued a complete response letter (CRL) for Alvotech’s interchangeable BLA on 28 June 2023, noting issues at Alvotech’s facility in Reykjavik, Iceland.
Alvotech also reported that AVT04, its biosimilar to Stelara®, is filed and pending approval in 7 markets including U.S, EU, Japan, and Canada, and it is expecting some approvals to occur before end of 2023.
Alvotech published its financial results on 30 August 2023.Print Page Mail Article