FDA Approves Pertuzumab Biosimilar in Breast Cancer Indications

The FDA has approved pertuzumab-dpzb (Poherdy) as a biosimilar to pertuzumab (Perjeta) in breast cancer, based on a review of various attributes, including safety and efficacy data.

The FDA has approved pertuzumab-dpzb (Poherdy) as an interchangeable biosimilar to pertuzumab (Perjeta), according to a press release from the FDA.

Poherdy, a HER2/neu receptor antagonist, is indicated:

• in combination with trastuzumab (Herceptin) and docetaxel in adult patients with HER2-positive metastatic breast cancer not previously treated with anti-HER2 therapy or chemotherapy for metastatic disease;
• in combination with trastuzumab and chemotherapy as neoadjuvant therapy for adults with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer as part of a complete treatment regimen for early breast cancer;
• in combination with trastuzumab and chemotherapy as adjuvant treatment for adult patients with HER2-positive early breast cancer at high risk of recurrence.

Comparisons across a range of structural and functional product quality attributes, such as those that impact safety and efficacy, pharmacokinetic data, clinical immunogenicity data, and supportive clinical data in patients with breast cancer, supported the biosimilar's similarity to reference pertuzumab.

The recommended dose for pertuzumab-dpzb is 840 mg administered via a 60-minute intravenous infusion, followed every 3 weeks by 420 mg administered via a 30- to 60-minute intravenous infusion.

The warning label has a boxed warning for left ventricular dysfunction and embryo-fetal toxicity, and a warning for infusion-related reactions and hypersensitivity reactions/anaphylaxis.

Reference

FDA approves new interchangeable biosimilar to Perjeta. News release. FDA. November 13, 2025. Accessed November 13, 2025. https://tinyurl.com/2vzwt6ej