FDA Clears Alvotech Process to More Than Double Simlandi Drug Substance Output

Alvotech announced Oct. 20 that the U.S. Food and Drug Administration (FDA) had approved a manufacturing process that more than doubles Simlandi drug substance output per batch without changing upstream manufacturing scale.

The process applies to Alvotech’s DSM2 manufacturing suite in Reykjavik, Iceland. The increase refers to drug substance produced in each batch, rather than finished Simlandi doses.

The process approval follows a separate clearance announced Oct. 5. That earlier approval authorized the DSM2 suite to make Simlandi drug substance for the U.S. market.

Simlandi (adalimumab-ryvk) is Alvotech’s biosimilar to AbbVie’s Humira (adalimumab). Alvotech manufactures Simlandi, and Teva Pharmaceuticals is its exclusive U.S. commercial partner.