Alvotech (ALVO) Form 6-K — Oct 5, 2026
Alvotech announced that the FDA approved a supplement to the BLA for AVT02 (adalimumab-ryvk), marketed in the U.S. as SIMLANDI, enabling drug substance production in a second suite (DSM2) at its Reykjavik facility. The addition of DSM2 effectively doubles the manufacturing capacity available to support U.S. supply, and the company says the approval further confirms resolution of FDA inspection-related matters at the site following a July 2026 VAI classification.
Key figures
- Countries avt02 approved
- more than 50
- Fda inspection classification
- Voluntary Action Indicated (VAI), July 2026
- Manufacturing capacity effect
- DSM2 doubles drug substance manufacturing capacity available to support U.S. supply
AI analysis
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