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Alvotech (ALVO) Is Up 7.5% After FDA Accepts Review Of Key Entyvio Biosimilar AVT80

Simply Wall St · 1d ago
  • Alvotech recently announced that the FDA accepted for review its Biologics License Application for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) in prefilled syringe and autoinjector forms for subcutaneous use, under its commercialization partnership with Teva.
  • This milestone, supported by pivotal pharmacokinetic and immunogenicity data and aligned with parallel U.S. and EU filings for AVT16 and AVT80, underscores Alvotech’s push to broaden access to immunology biosimilars across both intravenous and subcutaneous formulations.
  • We’ll now examine how FDA review of AVT80 as a potential interchangeable biosimilar could reshape Alvotech’s investment narrative and pipeline outlook.

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Alvotech Investment Narrative Recap

To own Alvotech, you have to believe its expanding biosimilar portfolio can convert regulatory wins into durable product revenue, despite price pressure and a heavy debt load. The FDA’s review of AVT80, alongside AVT16, strengthens the near term catalyst around Entyvio biosimilars, but it does not remove the core risks of approval timing, milestone lumpiness and reliance on partners like Teva.

Among recent developments, the FDA’s earlier acceptance of the AVT16 BLA for intravenous Entyvio is most relevant, as AVT16 and AVT80 together target both IV and subcutaneous use. Coupled with EMA validation in Europe, these filings could become a key driver for Alvotech’s 2026 revenue guidance of US$650 million to US$700 million if approvals arrive broadly in line with expectations.

Yet, against that opportunity, investors should be aware of how delays or setbacks in these Entyvio programs could affect liquidity, given the company’s substantial debt and...

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

Alvotech's narrative projects $1.0 billion revenue and $242.3 million earnings by 2029. This requires 22.2% yearly revenue growth and a $323.0 million earnings increase from -$80.7 million today.

Uncover how Alvotech's forecasts yield a $5.75 fair value, a 8% upside to its current price.

Exploring Other Perspectives

ALVO 1-Year Stock Price Chart
ALVO 1-Year Stock Price Chart

The most cautious analysts were already assuming around US$983 million of 2029 revenue and only US$82.7 million of earnings, highlighting how differently you might weigh regulatory timing risk even before factoring in the AVT80 news.

Explore 5 other fair value estimates on Alvotech - why the stock might be worth over 4x more than the current price!

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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.