FDA approves new interchangeable biosimilar to Perjeta

Regulatory approval: On Nov 13, 2025, the FDA approved Poherdy (pertuzumab-dpzb; Shanghai Henlius Biologics) as an interchangeable biosimilar to Perjeta (pertuzumab). This is the first FDA-approved biosimilar for Perjeta. Poherdy is indicated with trastuzumab plus docetaxel for certain adults with HER2-positive metastatic breast cancer, and with trastuzumab plus chemotherapy in neoadjuvant and adjuvant settings for specified HER2-positive early/locally advanced breast cancer. Labeling includes boxed warnings for left ventricular dysfunction and embryo-fetal toxicity.

FDA approval: Poherdy, an interchangeable biosimilar to Perjeta

Type: Regulatory approval
Date: 2025-11-13
Agency: US FDA

On November 13, 2025, the FDA approved Poherdy (pertuzumab-dpzb; Shanghai Henlius Biologics Co. Ltd.) as an interchangeable biosimilar to Perjeta (pertuzumab; Genentech Inc.). The FDA stated this is the first approval of a biosimilar for Perjeta.

Indications (HER2/neu receptor antagonist)

Poherdy is indicated:

  • With trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
  • With trastuzumab and chemotherapy as:
    • Neoadjuvant treatment for adults with HER2-positive locally advanced, inflammatory, or early-stage breast cancer (>2 cm or node-positive) as part of a complete regimen.
    • Adjuvant treatment for adults with HER2-positive early breast cancer at high risk of recurrence.

Basis for approval

The FDA cited comparisons across structural/functional quality attributes, human pharmacokinetics, clinical immunogenicity, and supportive clinical data in breast cancer demonstrating Poherdy is biosimilar to and interchangeable with Perjeta.

Key safety and dosing information (label)

Boxed warning: left ventricular dysfunction and embryo-fetal toxicity. Warnings/precautions include infusion-related reactions and hypersensitivity/anaphylaxis. Recommended dosing: 840 mg IV over 60 min, then 420 mg IV every 3 weeks over 30–60 min.

Full prescribing information will be posted on Drugs@FDA.

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