News

News

Fresenius Kabi and Polpharma Submit aBLA for Proposed Entyvio® (vedolizumab) Biosimilar PB016

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

On July 31, 2026, Fresenius Kabi and Polpharma announced the FDA acceptance of their aBLA for PB016 (vedolizumab), a proposed intravenous biosimilar of Takeda’s Entyvio® (vedolizumab).  They also announced the acceptance of their Marketing Authorisation Application (MAA) by the EMA for PB016.

This is the second publicly announced aBLA for an Entyvio® biosimilar, following Alvotech’s announcement of its aBLA for AVT16 in June 2026 (previously reported Alvotech Announces First FDA Acceptance of aBLA for Proposed Entyvio® Biosimilar – AVT16).

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.

 

_____________________________________________________

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.

    Disclaimer

    The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

    Subscribe for Future Updates

      captcha