28 June 2023 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s second biologics license application for AVT02, a high-concentration biosimilar candidate for Humira (adalimumab). 

As the second of two BLAs submitted for AVT02, this BLA contained data to support approval as a high-concentration biosimilar and additional information to support the interchangeability designation.

Read Alvotech press release