Alvotech (ALVO) Is Down 38.6% After FDA Delays AVT05 Biosimilar Approval and Cuts Revenue Outlook

• In November 2025, Alvotech announced that the U.S. FDA issued a complete response letter for the Biologics License Application of AVT05, a biosimilar to Simponi, highlighting deficiencies in the Reykjavik manufacturing facility that must be resolved before approval, though the site remains FDA-approved for current products.
• The delay in AVT05’s approval prompted Alvotech to lower its 2025 revenue outlook to between US$570 million and US$600 million, as additional investments are required to address the facility issues and temporarily slow production.
• We’ll explore how this regulatory setback and the revised financial outlook impact Alvotech’s investment narrative and longer-term market positioning.

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Alvotech Investment Narrative Recap

Owning Alvotech depends on believing in consistent execution on a broad pipeline of biosimilars, securing timely regulatory approvals, and translating scientific and operational achievements into reliable cash flow. The recent FDA complete response letter regarding AVT05 delays a critical approval, meaning the biggest near-term catalyst, US market entry for this biosimilar, faces a direct short-term setback. At the same time, the most material risk, revenue "lumpiness" from regulatory-dependent milestones, comes to the forefront, as management has already trimmed its 2025 outlook following the news.

Among recent company announcements, the EMA's acceptance of the AVT23 application (biosimilar to Xolair) stands out, as it signals ongoing pipeline momentum even as the AVT05 delay unfolds in the US. This EMA milestone helps balance the narrative for investors focused on global regulatory progress as a key catalyst, though continued US regulatory headwinds could affect sentiment and near-term execution on guidance.

However, investors should know that, even with approvals in place elsewhere, the effect of regulatory delays on milestone-driven revenue can...

Read the full narrative on Alvotech (it's free!)

Alvotech's narrative projects $1.4 billion revenue and $538.9 million earnings by 2028. This requires 36.7% yearly revenue growth and a $475.5 million increase in earnings from $63.4 million today.

Uncover how Alvotech's forecasts yield a $16.10 fair value, a 233% upside to its current price.

Exploring Other Perspectives

You have 7 fair value estimates from the Simply Wall St Community, stretching from US$14 to US$2,650.56 per share. With recent regulatory delays and revised revenue targets, your view on milestone risk could shape your own assessment just as strongly, consider alternative outlooks before making any decisions.

Explore 7 other fair value estimates on Alvotech - why the stock might be a potential multi-bagger!

Build Your Own Alvotech Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Alvotech research is our analysis highlighting 3 key rewards and 4 important warning signs that could impact your investment decision.
• Our free Alvotech research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Alvotech's overall financial health at a glance.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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