News

News

Genentech and Shanghai Henlius Biotech Settle Perjeta® Biosimilar BPCIA Litigation

by Robert S. Schwartz, Ph.D.
February 3, 2026

On January 30, 2026, the Court ordered Genentech / Hoffmann-La Roche and Shanghai Henlius Biotech / Organon’s stipulated dismissal of Case No. 2:25-cv-14648 (D.N.J.) due to a settlement agreement between the parties.  The case, a BPCIA litigation filed in August 2025 (previously reported Genentech Files First BPCIA Litigation Against Perjeta® (pertuzumab) Biosimilar Applicant), alleged infringement of 24 patents by Poherdy® (pertuzumab-dpzb), an interchangeable biosimilar of Perjeta® (pertuzumab), approved by the FDA in November 2025 (previously reported FDA Approves First Perjeta® Biosimilar: Shanghai Henlius Biotech / Organon’s Poherdy®).  The Court filings did not give any details about the terms of the settlement agreement.

This case was the only pending patent proceeding related a Perjeta® biosimilar, and there are currently no pending publicly announced aBLAs for Perjeta® biosimilars.

Roche reported U.S. sales of approximately $1.486B USD (1.345B CHF) for Perjeta® in 2024.

For more information about this and other biosimilars and biosimilar patent disputes, 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