On September 1, 2026, Takeda filed BPCIA litigation No. 2:26-cv-11301 (D.N.J.) against Alvotech’s proposed Entyvio^® (vedolizumab) interchangeable biosimilar AVT16.  This lawsuit was filed just days after Takeda’s case against Polpharma’s PB016 (vedolizumab) (previously reported Takeda Files First BPCIA Litigation Against Proposed Entyvio^® (vedolizumab) Biosimilar, Polpharma’s PB016) and asserts the same six method of treatment patents.

Alvotech and Teva announced the acceptance of their aBLA for AVT16, an intravenous presentation of vedolizumab, in June 2026 (previously reported Alvotech Announces First FDA Acceptance of aBLA for Proposed Entyvio^® Biosimilar – AVT16), and a second aBLA for AVT80, a subcutaneous presentation of vedolizumab, in August 2026 (previously reported Second Proposed Interchangeable Vedolizumab aBLA from Alvotech and Teva Accepted by FDA).  The current lawsuit alleges infringement by the intravenous presentation, AVT16.

According to the Complaint, the parties did not participate in the BPCIA patent dance due to a disagreement over the terms of a confidentiality agreement for production of Alvotech’s aBLA.

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.