FDA clears Alvotech to make SIMLANDI drug substance in second Reykjavik suite for US supply
ALVO•The FDA cleared Alvotech to produce SIMLANDI drug substance in a second Reykjavik suite, effectively doubling U.S.-eligible capacity for the Humira biosimilar.
1. Added U.S. capacity
The clearance enables production of AVT02 drug substance from a second Reykjavik suite, expanding supply flexibility for the U.S. market. It follows the FDA’s July 2026 VAI classification for the facility.
