Alvotech Shares Plunge 33% After FDA Flags Issues

Core Points - Alvotech's stock (NASDAQ:ALVO) is experiencing a significant decline, trading down 33.99% at $5.05, with a session volume of 2.32 million compared to an average volume of 395.34 thousand [1][6] - The U.S. FDA issued a complete response letter (CRL) for Alvotech's Biologics License Application (BLA) for AVT05, a biosimilar candidate to Johnson & Johnson's Simponi, indicating deficiencies that must be resolved before approval [3][4] - Alvotech's total revenue outlook for 2025 has been revised to $570-$600 million, with adjusted EBITDA expectations lowered to $130-$150 million, primarily due to ongoing investments to address facility issues [5][6] Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines, which are biological drugs highly similar to existing approved biologics [2] - The manufacturing facility in Reykjavik remains FDA-approved and continues to supply currently commercialized products despite the CRL [4] Market Context - Sales of Simponi in the U.S. for the first half of 2025 were reported to be less than $300 million, with no FDA approvals for a biosimilar to Simponi currently available [5]