FDA Approves Enhanced Manufacturing Process for Alvotech's Biosimilar SIMLANDI®

The U.S. Food and Drug Administration (FDA) has approved a new manufacturing process (Process 2.0) for Alvotech's adalimumab biosimilar, SIMLANDI® (adalimumab-ryvk). This advancement more than doubles the drug substance output per batch, significantly increasing manufacturing productivity and freeing up capacity to support other biosimilars in Alvotech's portfolio.