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.
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The authors would like to thank April Breyer Menon for her contributions to this article.
