Alvotech Revises 2025 Outlook After FDA CRL on AVT05 Biosimilar

Alvotech, a global biotech company specializing in biosimilar medicines, received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application for AVT05, a biosimilar candidate to Simponi. The FDA's concerns stem from deficiencies identified during a pre-license inspection of Alvotech's Reykjavik manufacturing facility, which must be resolved before approval can be granted, though the facility remains approved for manufacturing other products. Alvotech promptly submitted a Corrective and Preventive Action plan to address these issues and is actively working with the FDA to secure approval for AVT05, which would be the first biosimilar alternative to Simponi in the U.S. market. Due to this regulatory setback and ongoing investments in facility upgrades and compliance, Alvotech revised its 2025 financial outlook, lowering revenue expectations to $570-$600 million and adjusted EBITDA to $130-$150 million. Despite strong revenue growth, the company faces financial risks highlighted by an Altman Z-Score indicating potential distress, emphasizing the importance of managing its high leverage effectively.