FDA Accepts Alvotech's BLA for AVT80, Subcutaneous Entyvio Biosimilar
ALVO sits 69% above its 52-week low of $2.94.
Summary
Alvotech announced FDA acceptance for review of its BLA for AVT80, a proposed interchangeable subcutaneous biosimilar to Entyvio, expanding its vedolizumab program alongside AVT16.
Key Events · Product Development and Regulatory · ALVO
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FDA Accepts AVT80 BLA for Review
The FDA has accepted for review Alvotech's Biologics License Application for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) in prefilled syringe and autoinjector forms for subcutaneous administration.
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Expands Vedolizumab Program
AVT80 complements AVT16, the intravenous presentation whose BLA was accepted in May 2026, giving Alvotech both subcutaneous and intravenous candidates for the Entyvio biosimilar program.
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Teva Partnership
Under the partnership, Alvotech is responsible for development and manufacturing of AVT80, while Teva handles commercialization.
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Pivotal Study Support
The BLA is supported by a comprehensive data package including positive results from a pivotal pharmacokinetic study announced in February 2026 that met all primary endpoints.
Analysis · ALVO · Life Sciences
The FDA's acceptance of the AVT80 BLA for review marks a meaningful regulatory milestone for Alvotech, extending its vedolizumab biosimilar program into subcutaneous presentations and complementing the intravenous AVT16 candidate accepted in May 2026. This progress is particularly significant for a company that has recently raised substantial capital and reported a net loss, as it advances a pipeline asset toward potential approval and commercialization under the Teva partnership.
How filings like this one have moved
In the 30 days to Nov 2, 2026, 32.7% of the 1910 measured filings Wiseek scored 7 moved their stock by 5% or more by the next session's close. The median move was 0.00%. These are measured outcomes after filings of this importance, not a forecast for this one.
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At the time of this filing, ALVO was trading at $4.96 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.9B. The 52-week trading range was $2.94 to $9.25. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.