Alvotech Receives FDA Approval for Enhanced SIMLANDI® Manufacturing Process

Alvotech, a biotechnology company specializing in biosimilar medicines, has received FDA approval for a new manufacturing process for SIMLANDI® (adalimumab-ryvk), its biosimilar to Humira®. This enhanced process, Process 2.0, more than doubles the drug substance output per batch, increasing manufacturing productivity and freeing up capacity to support Alvotech's growing biosimilars portfolio.