- Alvotech said the FDA approved a supplement to the Biologics License Application for AVT02, its biosimilar to Humira marketed in the US as Simlandi, enabling drug substance for US commercial supply to be manufactured in a second suite at its Reykjavik plant.
- The second suite, DSM2, supports the full drug substance process including cell culture and purification and doubles the manufacturing capacity available for US supply; it is already approved for European commercial supply of AVT02, AVT03 and AVT05.
- The approval follows the FDA's July 2026 closure of its most recent Reykjavik inspection with a Voluntary Action Indicated classification, and Alvotech expects the FDA to act on pending BLAs for AVT05, AVT06, AVT03 and AVT16/AVT80 according to their goal dates.
- Teva Pharmaceuticals is Alvotech's strategic partner for exclusive commercialization of Simlandi in the United States, while Alvotech handles development and manufacturing.
Quotes
“The addition of DSM2 effectively doubles the drug substance manufacturing capacity available to support U.S. supply and provides greater flexibility for commercial supply of AVT02 to the U.S. market.”