FDA Approves New Manufacturing Process for Alvotech's Biosimilar SIMLANDI® (adalimumab-ryvk)

The U.S. Food and Drug Administration (FDA) has approved a new manufacturing process (Process 2.0) for Alvotech's biosimilar SIMLANDI® (adalimumab-ryvk), a biosimilar to Humira®. This approval allows Alvotech to more than double the drug substance output per batch without altering the upstream manufacturing scale, enhancing production efficiency and capacity. The company stated this improvement provides greater flexibility to meet growing demand for its biosimilars.