ALVO

Announcements

Nothing here yet

Daily updates

• Alvotech received FDA approval for SIMLANDI drug substance production in a second Reykjavik manufacturing suite, effectively doubling U.S. capacity.Oct 5, 2026

FDA designations

Nothing here yet

News

• Alvotech and Advanz Pharma announce the first known worldwide regulatory submission for a proposed Eylea 8 mg biosimilarOct 14, 2026
• Alvotech and LOTTE Biologics announce a U.S.-based manufacturing agreement to expand global supplyOct 6, 2026
• FDA approves additional U.S. manufacturing capacity for Alvotech's SIMLANDI, a biosimilar to HumiraOct 5, 2026
• Alvotech received FDA acceptance for review of its BLA for AVT80, expanding its proposed Entyvio biosimilar program to subcutaneous formulationsAug 31, 2026
• Alvotech successfully completed the FDA inspection of its manufacturing facilityJul 31, 2026