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Alvotech Announces First FDA Acceptance of aBLA for Proposed Entyvio® Biosimilar – AVT16

by Leah Watson; Robert S. Schwartz, Ph.D.
June 11, 2026

On June 8, 2026, Alvotech announced that the FDA accepted for review its abbreviated Biologics License Application (“aBLA”) for AVT16, a proposed interchangeable biosimilar to Takeda’s Entyvio® (vedolizumab). AVT16 is the first publicly announced aBLA accepted by the FDA for a proposed Entyvio® biosimilar.

Entyvio® is an integrin receptor antagonist indicated in adults for the treatment of moderate to severe active ulcerative colitis and moderate to severe active Crohn’s disease. According to Alvotech’s press release, the aBLA is supported by analytical, pharmacokinetic, and immunogenicity data, and Alvotech expects a potential FDA decision in the first quarter of 2027. If approved, AVT16 will be marketed in the United States by Teva.

Currently, there are no pending patent disputes related to Entyvio® biosimilars, and no patents are listed in the Purple Book for Entyvio®.

Takeda reported FY2025 (Apr. 1, 2025 – Mar. 31, 2026) U.S. sales of JPY 623.7 billion (approximately $3.89 billion USD) for Entyvio®.

For more information about these and other biosimilars, please visit BiologicsHQ.

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The authors would like to thank April Breyer Menon for her contributions to this article.

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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