FDA Approves New Pertuzumab Biosimilar for Select HER2+ Breast Cancer Subtypes

The FDA has approved pertuzumab-dpzb (Poherdy) as an interchangeable biosimilar to the reference drug pertuzumab (Perjeta) across several indications in HER2-positive breast cancer.1

Of note, this regulatory decision marks the first approval of a biosimilar for pertuzumab.

Pertuzumab-dpzb is approved for the following indications:

• in combination with trastuzumab (Herceptin) and docetaxel for adult patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
• in combination with trastuzumab and chemotherapy as neoadjuvant therapy in 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.
• in combination with trastuzumab and chemotherapy as adjuvant therapy for adults with HER2-positive early breast cancer at high risk of recurrence.

This regulatory decision was supported by comparisons across a broad range of structural and functional product quality attributes, including those known to impact safety and efficacy; pharmacokinetic data; clinical immunogenicity data. Clinical data demonstrating that the agent is biosimilar to, and interchangeable with, pertuzumab in patients with breast cancer also informed the approval.

The recommended initial dose of pertuzumab-dpzb is 840 mg. The agent is administered as a 60-minute intravenous infusion, followed by a 420 mg infusion every 3 weeks over 30 to 60 minutes.

What is the agent's safety profile?

The prescribing information for pertuzumab-dpzb contains a boxed warning for left ventricular dysfunction and embryo-fetal toxicity, in addition to warnings and precautions for infusion-related reactions and hypersensitivity reactions/anaphylaxis.

In the metastatic setting, the most common adverse effects (AEs; >30%) associated with pertuzumab in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy.2

In the neoadjuvant setting, common AEs (> 30%) with pertuzumab-containing regimens are as follows:

• when used in combination with trastuzumab and docetaxel: alopecia, diarrhea, nausea, and neutropenia.
  • If the combination is administered after 3 cycles of fluorouracil, epirubicin and cyclophosphamide (FEC), common reactions include fatigue, alopecia, diarrhea, nausea, vomiting, and neutropenia.
• when used in combination with docetaxel, carboplatin, and trastuzumab: fatigue, alopecia, diarrhea, nausea, vomiting, neutropenia, thrombocytopenia, and anemia.
• when used in combination with trastuzumab and paclitaxel following 4 cycles of dose dense doxorubicin and cyclophosphamide: nausea, diarrhea, alopecia, fatigue, constipation, peripheral neuropathy, and headache.
• when used alongside trastuzumab and docetaxel following 4 cycles of FEC: diarrhea, nausea, alopecia, asthenia, constipation, fatigue, mucosal inflammation, vomiting, myalgia, and anemia.

In the adjuvant setting, the most common adverse reactions (>30%) associated with pertuzumab combined with trastuzumab and chemotherapy generally are diarrhea, nausea, alopecia, fatigue, peripheral neuropathy, and vomiting.

References

1. FDA approves new interchangeable biosimilar to Perjeta. News Release. November 13, 2025. Accessed November 13, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-interchangeable-biosimilar-perjeta.
2. Poherdy. Prescribing information. FDA; 2025. Accessed November 13, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761450s000lbl.pdf