Alvotech Shares Plunge 33% After FDA Flags Issues
1. ALVO received a complete response letter (CRL) from the FDA. 2. Deficiencies noted in the BLA for AVT05 biosimilar to Simponi. 3. Total revenue outlook for 2025 revised to $570-$600 million. 4. ALVO stock dropped 33.99% to $5.05 following the news. 5. Current FDA approvals for a Simponi biosimilar remain unachieved.