FDA Approves First Interchangeable Biosimilar to Perjeta (pertuzumab) Genentech

On November 13, 2025, the FDA approved Poherdy (pertuzumab-dpzb, by Shanghai Henlius Biologics Co., Ltd.) as an interchangeable biosimilar to Perjeta (pertuzumab, by Genentech Inc.). U.S. Food and Drug Administration

This marks the first biosimilar approved for Perjeta. U.S. Food and Drug Administration

Indications for Poherdy include:

• Combination with trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer who have not had prior anti-HER2 therapy or chemo for metastatic disease. U.S. Food and Drug Administration
• Combination with trastuzumab and chemo as neoadjuvant treatment in adults with HER2-positive, locally advanced, inflammatory or early-stage breast cancer (either >2 cm or node positive). U.S. Food and Drug Administration
• Adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence. U.S. Food and Drug Administration

The approval rests on comprehensive data comparing product quality (structure/function), pharmacokinetics, immunogenicity, and clinical efficacy/safety — showing biosimilarity and the interchangeable status. U.S. Food and Drug Administration

Key safety information: boxed warning for left-ventricular dysfunction and embryo-fetal toxicity; also warnings for infusion-related reactions and hypersensitivity/anaphylaxis. U.S. Food and Drug Administration

Recommended dosing: initial dose 840 mg IV over ~60 min, then 420 mg every 3 weeks IV over 30-60 min. U.S. Food and Drug Administration