TLDR
- FDA setback hits Alvotech’s AVT05, triggering revised 2025 outlook.
- Alvotech tackles FDA issues with compliance-driven upgrades ahead.
- AVT05 delay reshapes Alvotech’s 2025 goals but fuels long-term growth.
- FDA flags Alvotech site; company revamps strategy for biosimilar push.
- Alvotech slows output to fix FDA concerns and power future launches.
Alvotech(ALVO) stock closed at $7.65, falling 2.42%, after the U.S. Food and Drug Administration issued a Complete Response Letter for its biosimilar AVT05.
Alvotech, ALVO
The letter followed a pre-license inspection of Alvotech’s Reykjavik manufacturing site, identifying deficiencies that require resolution before approval. The regulatory delay has led the company to revise its 2025 financial outlook, reflecting reduced revenue and profitability expectations.
FDA Identifies Facility Deficiencies in AVT05 Review
The FDA issued a Complete Response Letter for Alvotech’s Biologics License Application for AVT05, a biosimilar candidate to Simponi. The agency cited deficiencies found during its inspection of Alvotech’s Reykjavik facility, which concluded in July 2025. However, the facility remains approved for manufacturing and continues to produce currently marketed biosimilars.
The FDA noted that the deficiencies must be resolved before granting approval for AVT05. No additional issues were identified in the application, indicating that the primary concern lies within operational compliance. Alvotech submitted a detailed Corrective and Preventive Action plan, addressing the inspection findings to the agency for review.
The company reaffirmed that it remains focused on securing FDA clearance for AVT05. It continues to coordinate with the agency to address all outstanding matters. Once approved, AVT05 would become the first biosimilar alternative to Simponi available in the U.S. market.
Revised 2025 Financial Outlook Reflects Temporary Production Slowdown
Following the FDA letter, Alvotech adjusted its 2025 revenue forecast to between $570 million and $600 million. The company expects adjusted EBITDA between $130 million and $150 million, lower than earlier projections. The revised figures primarily reflect ongoing investments in facility upgrades and compliance improvements.
These measures require a temporary slowdown in production while enhancing long-term operational efficiency. The company confirmed that the corrective efforts would strengthen its manufacturing framework for future biosimilar launches. Despite near-term pressure on margins, Alvotech expects these actions to support sustainable growth.
Alvotech’s leadership remains confident about overcoming the current regulatory hurdle. It continues to prioritize quality standards and compliance as part of its long-term strategy. The firm maintains its commitment to expanding its biosimilar portfolio across global markets.
Market Context and Pipeline Expansion
Simponi, marketed by Johnson & Johnson, generated less than $300 million in U.S. sales in the first half of 2025. Currently, there are no approved biosimilars for Simponi in the United States. A future approval for AVT05 would position Alvotech as a first entrant in this therapeutic category.
The company’s manufacturing site in Reykjavik remains operational, supplying approved products to multiple regions. Its ongoing upgrades demonstrate a strategic effort to ensure compliance and scalability. These initiatives align with its broader goal of leading the global biosimilar segment.
Alvotech operates a fully integrated platform dedicated to developing biosimilars for autoimmune and other chronic conditions. Its disclosed pipeline includes eight biosimilar candidates targeting diseases such as cancer, osteoporosis, and respiratory disorders. Through commercial partnerships across major global markets, Alvotech aims to expand patient access to affordable biologic medicines.
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