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How Investors Are Reacting To Alvotech (ALVO) EU Approval Of AVT03 Denosumab Biosimilar

Simply Wall St · 2d ago
  • Alvotech recently announced that the European Commission has approved AVT03 as a biosimilar to denosumab (Prolia and Xgeva), opening access to an estimated US$1.20 billion European market for osteoporosis and cancer-related bone complications, with commercialization in Europe to be led by Dr. Reddy's under the Acvybra and Xbonzy brands.
  • The approval, grounded in extensive analytical and clinical data showing equivalent pharmacokinetics, efficacy, safety and immunogenicity to the originators, also serves as a meaningful regulatory endorsement of Alvotech's broader biosimilar platform and manufacturing capabilities.
  • We’ll now examine how gaining European Commission approval for AVT03 reshapes Alvotech’s investment narrative around regulatory execution and biosimilar market expansion.

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Alvotech Investment Narrative Recap

To own Alvotech, you need to believe its “TSMC of biologics” ambition can translate into recurring biosimilar revenues despite regulatory and pricing pressures. The AVT03 EC approval reinforces the company’s regulatory execution and adds a meaningful new market, but it does not change that the key near term catalyst remains resolving FDA concerns around AVT05, while the biggest risk is continued regulatory or inspection related delays that disrupt the timing of milestone driven revenue.

The most relevant recent news alongside AVT03 is the FDA Complete Response Letter for AVT05 tied to Alvotech’s Reykjavik facility. Together, these events highlight a bifurcated picture for investors: strong validation from European regulators on one hand, and US regulatory setbacks on a core asset on the other, both of which directly influence how “lumpy” approval based milestone payments and near term earnings will be.

Yet investors also need to be aware that, despite new approvals, unresolved manufacturing and inspection issues could still...

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

Alvotech's narrative projects $1.4 billion revenue and $538.9 million earnings by 2028.

Uncover how Alvotech's forecasts yield a $26.40 fair value, a 421% upside to its current price.

Exploring Other Perspectives

ALVO Community Fair Values as at Dec 2025
ALVO Community Fair Values as at Dec 2025

Seven members of the Simply Wall St Community value Alvotech between US$14 and US$2,650.56, underscoring how far apart individual views can be. When you layer in the risk that regulatory delays may disrupt milestone based revenue, it becomes even more important to compare these contrasting perspectives on what could drive the company’s performance.

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

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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.