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Second Proposed Interchangeable Vedolizumab aBLA from Alvotech and Teva Accepted by FDA

by Robert S. Schwartz, Ph.D.
September 2, 2026

On August 31, 2026, Alvotech and Teva announced the FDA acceptance of an aBLA for AVT80 (vedolizumab), a proposed interchangeable biosimilar of Takeda’s Entyvio® (vedolizumab).  AVT80 is a subcutaneous presentation of vedolizumab in a prefilled syringe and autoinjector.  In June 2026, Alvotech and Teva announced the acceptance of an aBLA for an intravenous presentation of vedolizumab, AVT16 (previously reported Alvotech Announces First FDA Acceptance of aBLA for Proposed Entyvio® Biosimilar – AVT16).

There is currently a pending BPCIA litigation between Takeda and Polpharma, Case No. 3:26-cv-11002 (D.N.J.), related to Polpharma’s proposed Entyvio® biosimilar PB016 (previously reported Takeda Files First BPCIA Litigation Against Proposed Entyvio® (vedolizumab) Biosimilar, Polpharma’s PB016), an aBLA for which was accepted by the FDA in July 2026 (previously reported Fresenius Kabi and Polpharma Submit aBLA for Proposed Entyvio® (vedolizumab) Biosimilar PB016).

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 author 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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