Herceptin Biosimilar Herzuma Approved for Certain Breast Cancer Indications


The FDA has approved Celltrion and Teva’s Herzuma (trastuzumab-pkrb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer. Herzuma is the second oncology biosimilar approval in the United States in the past month.

Specifically, Herzuma is approved to treat:

  • Adjuvant breast cancer of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; or as part of a treatment regimen with docetaxel and carboplatin
  • Metastatic breast cancer in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer; or as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.

Understanding Biosimilar Drugs

The approval was based on the totality of evidence demonstrating Herzuma as a biosimilar to the reference product for the approved indications. The Agency reviewed and analyzed similarity data, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data. No clinically meaningful differences were seen in purity, potency, and safety between Herzuma and the reference product for the treatment of certain HER2-overexpressing breast cancer indications.

Headache, diarrhea, nausea, chills, fever, headache, infection, congestive heart failure, insomnia, cough, and rash were the most commonly reported adverse events. Herzuma, a HER2/neu receptor antagonist, carries a Boxed Warning describing cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity.

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