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News

FDA Approves first Perjeta® Biosimilar: Shanghai Henlius Biotech / Organon’s Poherdy®

by Leah Watson; Robert S. Schwartz, Ph.D.
November 25, 2025

On November 13, 2025, the FDA approved Shanghai Henlius Biotech / Organon’s Poherdy® (pertuzumab-dpzb) as the first interchangeable biosimilar of Genentech’s Perjeta® (pertuzumab). Poherdy® is approved for all of the same indications as Perjeta®.  There is an ongoing patent dispute between the parties over Poherdy®, Case No. 2:25-cv-14648 (D.N.J.) (see previously reported Genentech Files First BPCIA Litigation Against Perjeta® (pertuzumab) Biosimilar Applicant). There are no other pending patent disputes or publicly disclosed 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.

 

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The authors 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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