On November 13, 2025, the FDA approved Shanghai Henlius Biologics Co. Ltd.’s POHERDY (pertuzumab-dpzb) as an interchangeable biosimilar to Genentech’s PERJETA (pertuzumab). This is the first pertuzumab biosimilar to receive FDA approval.
Pertuzumab is a HER2 inhibitor that is administered via an intravenous infusion with other agents and chemotherapies. POHERDY is indicated for use in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Additionally, POHERDY is indicated for use with trastuzumab and chemotherapy as neoadjuvant treatment for adults with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (tumors larger than 2 cm or node-positive), as part of a complete regimen for early breast cancer, and as adjuvant treatment for HER2-positive early breast cancer in adults at high risk of recurrence.
As we previously reported, on August 14, 2025, Genentech filed a BPCIA complaint against Shanghai Henlius, and its commercial partner Organon, alleging that Shanghai Henlius’s pertuzumab biosimilar infringes 24 patents. The case is pending and remains the only BPCIA litigation involving a pertuzumab biosimilar. A scheduling conference is set for December 10, 2025.
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