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Takeda Files First BPCIA Litigation Against Proposed Entyvio® (vedolizumab) Biosimilar, Polpharma’s PB016

by Robert S. Schwartz, Ph.D.
August 28, 2026

On August 26, 2026, Takeda Pharmaceuticals filed BPCIA Litigation No. 3:26-cv-11002 (D.N.J.) against Polpharma’s proposed Entyvio® (vedolizumab) biosimilar PB016, alleging infringement of six of Takeda’s method of treatment patents.  This is the first BPCIA litigation to be filed against a proposed Entyvio® biosimilar, and the patents have not been previously asserted in litigation.

Polpharma and Fresenius Kabi announced the FDA acceptance of their aBLA for PB016 at the end of July 2026 (previously reported Fresenius Kabi and Polpharma Submit aBLA for Proposed Entyvio® (vedolizumab) Biosimilar PB016).  According to Takeda’s Complaint, Polpharma gave its 180-day notice of commercial marketing on June 18, 2026 and then declined to participate in the BPCIA patent dance.

Alvotech and Teva announced the acceptance of their aBLA for AVT16 (vedolizumab) in June 2026 (previously reported Alvotech Announces First FDA Acceptance of aBLA for Proposed Entyvio® Biosimilar – AVT16).

Currently there are no other pending patent disputes related to Entyvio® biosimilars.

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 and biosimilar patent disputes, 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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