Alvotech stock gains on FDA review progress for AVT80

Published on 09/03/2026 at 17:20 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

Alvotech stock is in focus as the biotech group reports progress with the FDA review of its proposed interchangeable biosimilar AVT80, while investors weigh the latest revenue and loss figures from the most recent fiscal year and watch the Nasdaq-listed shares amid sector peers.

Alvotech, LU2557688560, Illustration mit AI erstellt.

Alvotech stock (ISIN LU2557688560) is drawing attention after the company announced that the U.S. Food and Drug Administration has accepted for review its Biologics License Application for AVT80, a proposed interchangeable biosimilar to Entyvio for subcutaneous use, with the update published on August 31, 2026 according to a GlobeNewswire release accessed on September 3, 2026.

FDA review of AVT80 shapes sentiment

According to the latest announcement from Alvotech, the FDA has accepted the BLA for AVT80, a biosimilar candidate referencing Entyvio (vedolizumab) administered via prefilled syringe and autoinjector for subcutaneous injection, signaling that the filing has passed the agency’s initial completeness check.

The company positions AVT80 as an interchangeable biosimilar, which, if approved, would allow pharmacists in the United States to substitute the product for the reference medicine subject to state pharmacy laws, a status that can be commercially significant in the inflammatory bowel disease market.

Financial backdrop: recent figures and losses

In its most recent reported fiscal year, Alvotech generated several hundred million USD of revenue from biosimilar products and collaboration agreements, but the company still posted a net loss for the period, reflecting ongoing investment in development, manufacturing capacity and regulatory filings; these figures provide important context for investors assessing the risk-reward balance of the stock.

Compared with the prior fiscal year, revenue increased by a double-digit percentage while net loss remained substantial, underscoring that while the top line is growing, the path to consistent profitability continues to depend on successful launches and scaling of key biosimilar assets such as AVT80.

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More on Alvotech and its stock

Investors can explore additional regulatory updates and detailed financial data for Alvotech to better understand the investment case behind the Nasdaq-listed biosimilar specialist.

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Biosimilar portfolio with Entyvio reference

One of Alvotech’s representative products is AVT80, which targets the Entyvio brand in inflammatory bowel disease and aims to offer an interchangeable biosimilar option for patients with ulcerative colitis and Crohn’s disease once approved.

Stock performance on Nasdaq

As of early September 2026, Alvotech stock trades on Nasdaq in USD alongside global biotech peers, with investors watching the share price reaction to the FDA’s decision to accept the AVT80 filing and the broader sentiment toward biosimilar developers.