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