FDA approval doubling SIMLANDI U.S. manufacturing capacity lifts Alvotech

 

• Alvotech announced the FDA decision at 4:00 a.m. ET Monday
• Approval adds a second Reykjavik production suite for U.S. SIMLANDI supply
• Management said DSM2 effectively doubles available U.S. drug-substance manufacturing capacity
• The decision further confirms resolution of FDA inspection-related Reykjavik manufacturing issues
• Approval supports expectations for FDA action on several other facility-linked biosimilar applications
• The premarket announcement explains the opening gap and continued regular-session advance
• The 16.6% gain substantially exceeds Alvotech’s recent 5%-6% average daily range

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