Alvotech (ALVO) Is Up 5.8% After EU Endorsement for Two Key Biosimilars Approvals

• Earlier this week, Alvotech and Advanz Pharma announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted positive opinions recommending approval for two key biosimilars: AVT03 (a proposed biosimilar to Prolia® and Xgeva®) and Gobivaz® (a biosimilar to Simponi®), marking regulatory milestones for the company in Europe.
• These endorsements position Alvotech to expand its commercial presence across Europe through established distribution partners, signaling potential for broader patient access and increased market penetration in the biosimilars segment.
• We’ll explore how these EU regulatory recommendations for biosimilar approvals reinforce Alvotech’s outlook on global market expansion and future earnings.

Find companies with promising cash flow potential yet trading below their fair value.

Alvotech Investment Narrative Recap

For investors looking at Alvotech, the central question is whether regulatory momentum in biosimilars, like this week's positive EMA opinions, can continue driving both commercial execution and pipeline value. While these regulatory wins support near-term visibility for new European launches, the most significant short-term catalyst remains timely product approvals, yet risks around "lumpy" milestone-based revenues and potential delays in regulatory timelines remain present and could still disrupt financial predictability.

Among recent announcements, the positive EMA opinion for AVT03, a proposed biosimilar to Prolia® and Xgeva®, stands out. This milestone, if followed by full approval and effective launches through partners STADA and Dr. Reddy's in Europe, reinforces one of the company's main catalysts: accelerating rollout of new biosimilars in major global markets to strengthen revenue streams and broaden market access.

However, despite the progress on new approvals, investors should watch for disruptions tied to regulatory delays or unexpected shifts in product launch timelines as these could materially impact...

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

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

Uncover how Alvotech's forecasts yield a $17.50 fair value, a 110% upside to its current price.

Exploring Other Perspectives

Six retail investors in the Simply Wall St Community set fair value estimates for Alvotech that range from US$14 to US$2,650.56 per share. Your outlook on risks like unpredictable milestone payments and possible regulatory delays may shape how you interpret this wide spectrum of value opinions.

Explore 6 other fair value estimates on Alvotech - why the stock might be worth just $14.00!

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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