Will EMA Acceptance of AVT23 Change Alvotech's (ALVO) Position in the Biosimilars Market?

• Advanz Pharma and Alvotech recently announced that the European Medicines Agency has accepted a Marketing Authorization Application for AVT23, a proposed biosimilar to Xolair® (omalizumab), with Advanz Pharma holding commercial rights across several major markets.
• This regulatory milestone highlights the growing significance of Alvotech's biosimilar pipeline in addressing demand for cost-effective biologic therapies in Europe and beyond.
• We'll examine how regulatory progress for AVT23 may reinforce Alvotech's position within the expanding global biosimilars market.

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Alvotech Investment Narrative Recap

To be an Alvotech shareholder, you need conviction in the global expansion of biosimilars and the company’s ability to secure regulatory approvals for its pipeline. The EMA’s acceptance of the AVT23 application underscores positive momentum, but the most critical catalyst, regulatory approval milestones driving near-term revenue, remains pending, with the unpredictable timing of such events continuing to pose the biggest risk to outlook. For now, while sentiment may be supported, the impact is not immediately material until approval decisions are reached.

Of recent announcements, the EMA’s positive opinion recommending approval for Alvotech’s other biosimilars like Gobivaz (Simponi) and AVT03 (Prolia) earlier this month stands out. This aligns closely with the AVT23 momentum, illustrating the potential revenue impact from multiple possible launches if regulatory timelines hold, but also highlighting how clustered approval risk shapes investor sentiment going forward.

Yet, should the regulatory process experience delays or shifting timelines, something investors should be watching for…

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

Alvotech's outlook anticipates $1.4 billion in revenue and $538.9 million in earnings by 2028. Achieving this would require annual revenue growth of 36.7% and an earnings increase of $475.5 million from the current $63.4 million.

Uncover how Alvotech's forecasts yield a $17.50 fair value, a 106% upside to its current price.

Exploring Other Perspectives

Six private investors in the Simply Wall St Community have estimated Alvotech’s fair value from US$14 up to US$2,650.56. With such far-reaching views, you should weigh this variety against ongoing regulatory risks that may affect when milestone-driven revenues actually materialize.

Explore 6 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 3 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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