FDA Approves First Interchangeable Biosimilar to Pertuzumab for HER2-Positive Breast Cancer
Key Clinical Takeaways
- Design/Population: Pertuzumab-dpzb (Poherdy) was approved as an interchangeable biosimilar to pertuzumab (Perjeta) for patients with HER2-positive metastatic, locally advanced, or early-stage breast cancer.
- Key Outcomes: Approval was supported by analytical and comparative clinical studies showing no clinically meaningful differences in safety, purity, or potency between pertuzumab-dpzb and the reference product.
- Clinical Relevance: This represents the first FDA-approved biosimilar to pertuzumab; carries boxed warnings for left ventricular dysfunction and embryo-fetal toxicity, with precautions for infusion and hypersensitivity reactions.
On November 13, 2025, the US Food and Drug Administration (FDA) approved pertuzumab-dpzb (Poherdy) as an interchangeable biosimilar to pertuzumab (Perjeta) for the treatment of patients with human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer.
Pertuzumab-dpzb is a HER2/neu receptor antagonist indicated for use in combination with trastuzumab and docetaxel for patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. It is also indicated in combination with trastuzumab and chemotherapy as neoadjuvant treatment for patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer that is either greater than 2 cm in diameter or node-positive, as part of a complete treatment regimen for early breast cancer. In addition, it is approved as adjuvant treatment for patients with HER2-positive early breast cancer at high risk of recurrence.
This approval was based on a totality of evidence, including extensive analytical characterization of structural and functional quality attributes and comparative clinical studies demonstrating no clinically meaningful differences between pertuzumab-dpzb and pertuzumab in terms of safety, purity, or potency.
The recommended dose of pertuzumab-dpzb is 840 mg administered as a 60-minute intravenous infusion, followed by 420 mg once every 3 weeks given over 30- to 60-minute infusions.
The prescribing information includes a boxed warning for left ventricular dysfunction and embryo-fetal toxicity, as well as additional warnings and precautions for infusion-related reactions and hypersensitivity reactions, including anaphylaxis.
This is the first FDA approval of a biosimilar referencing pertuzumab.
Source:
US Food and Drug Administration. FDA approves new interchangeable biosimilar to Perjeta. Accessed November 13, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-interchangeable-biosimilar-perjeta
