FDA approves SIMLANDI (adalimumab-ryvk) manufacturing process that more than doubles output per batch – Alvotech

Alvotech announced that the FDA has approved a new manufacturing process for SIMLANDI (adalimumab-ryvk), Alvotech’s biosimilar to Humira (adalimumab).

The FDA approval allows Alvotech to introduce Process 2.0 for the manufacture of adalimumab drug substance in its DSM2 manufacturing suite in Reykjavik, Iceland. The new process more than doubles drug substance output per batch without changing the upstream manufacturing scale. The improvement was achieved through targeted process development, effective process transfer and successful process validation, with demonstrated comparability to the previously approved process, maintaining product quality, safety and efficacy.

“More than doubling drug substance output per batch while maintaining product quality is a significant achievement that reflects the expertise of our process development and manufacturing teams,” said Joseph McClellan, Chief Operating Officer of Alvotech. “The new process allows us to manufacture the same quantity of drug substance in fewer batches, freeing up capacity to support other products in our portfolio, making better use of our existing infrastructure and giving us greater flexibility to respond to growing demand. Together with the recent FDA approval of additional manufacturing capacity, this demonstrates the strength of our operations in Reykjavik and reinforces our ability to deliver reliable supply to our commercial partners as demand for our biosimilars continues to grow.”