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# FDA Approves First Interchangeable Perjeta Biosimilar
- URL: https://www.fdaweb.com/fda-approves-first-interchangeable-perjeta-biosimilar/
- Published: 2025-11-13T12:00:00.000Z
- Updated: 2026-09-14T15:26:31.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160214

FDA has approved Shanghai Henlius Biologics’ Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Perjeta (pertuzumab), Genentech’s HER2-targeted therapy for breast cancer. Poherdy is described as a HER2/neu receptor antagonist indicated for use in combination with trastuzumab and chemotherapy in several settings, including:

- Metastatic breast cancer (MBC): for adults with HER2-positive disease who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
- Early-stage and locally advanced breast cancer: as neoadjuvant treatment for tumors greater than 2 cm or node-positive disease, and as adjuvant therapy for patients at high risk of recurrence.

An FDA release says the approval was based on a comprehensive review comparing Poherdy to Perjeta across a range of analytical, pharmacokinetic, and clinical parameters. Data from studies in patients with breast cancer demonstrated no clinically meaningful differences in safety, purity, or potency, supporting both biosimilarity and interchangeability — meaning pharmacists can substitute Poherdy for Perjeta without prescriber intervention, subject to state laws, it says.

Additionally, the agency notes that Poherdy carries the same Boxed Warning as Perjeta for left ventricular dysfunction and embryo-fetal toxicity, and includes Precautions for infusion-related reactions and hypersensitivity or anaphylaxis.