On November 13, 2025, the Food and Drug Administration approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co. Ltd.) as an interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc.). This is the first approval of a biosimilar for Perjeta.

Poherdy is a HER2/neu receptor antagonist indicated for the following:

  • use in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
  • use in combination with trastuzumab and chemotherapy as
    • neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.
    • adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.

Full prescribing information for Poherdy will be posted on Drugs@FDA.

The approval was based on comparisons across a broad range of structural and functional product quality attributes, including those known to impact safety and efficacy, human pharmacokinetic data, clinical immunogenicity data, and supportive clinical data in patients with breast cancer demonstrating that Poherdy is biosimilar to and interchangeable with Perjeta.

The prescribing information includes a boxed warning for left ventricular dysfunction and embryo-fetal toxicity, and warnings and precautions for infusion-related reactions and hypersensitivity reactions/anaphylaxis.

The recommended initial pertuzumab-dpzb dose is 840 mg administered as a 60-minute intravenous infusion, then followed every three weeks by a dose of 420 mg administered as an intravenous infusion over 30 to 60 minutes.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA's MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE's Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Follow the Oncology Center of Excellence on X: @FDAOncology.