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On January 30, 2026, the U.S. District Court for the District of New Jersey entered a Joint Stipulation of Dismissal resolving the pertuzumab BPCIA litigation between Genentech, Inc. and Hoffmann-La Roche Inc. (together, "Genentech") and Shanghai Henlius Biotech, Inc., Shanghai Henlius Biologics Co., Ltd., Organon LLC, and Organon & Co. after the parties entered into a confidential settlement agreement.
As we reported previously, Genentech filed its BPCIA complaint on August 14, 2025, asserting that Shanghai Henlius and Organon's pertuzumab biosimilar, POHERDY® (pertuzumab-dpzb), infringes 24 patents. In 2022, Shanghai Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to multiple biosimilars developed by Shanghai Henlius, including POHERDY®. On February 2, 2025, the FDA accepted Shanghai Henlius's BLA for its pertuzumab biosimilar, and on November 13, 2025, the FDA approved the product as interchangeable to Genentech's PERJETA® (pertuzumab).
In the Joint Stipulation of Dismissal, the parties agreed to voluntarily dismiss all claims and counterclaims with prejudice. The Joint Stipulation of Dismissal did not disclose any terms of the parties' settlement agreement.
Shanghai Henlius and Organon's POHERDY® is currently the only FDA-approved pertuzumab biosimilar, and no other BPCIA litigations have been filed to date.
Stay tuned to Big Molecule Watch and follow our BPCIA Litigations Tracker to stay up to date on pertuzumab and other BPCIA litigation news.
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