Herceptin Biosimilar Herzuma Approved for Certain Breast Cancer Indications

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The Agency reviewed similarity data, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data.
The Agency reviewed similarity data, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data.

Celltrion and Teva announced that the Food and Drug Administration (FDA) has approved Herzuma (trastuzumab-pkrb) injection, a new biosimilar to Herceptin (trastuzumab; Genentech) for certain HER2-overexpressing breast cancer indications. Patients should be selected for treatment based on an FDA-approved companion diagnostic for a trastuzumab product.

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

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.

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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.

Herzuma will be available as 420mg lyophilized powder in a multi-dose vial for reconstitution. It is not a substitute for or with ado-trastuzumab emtansine (Kadcyla; Genentech).

For more information call (888) 483-8279 or visit Herzuma.com.

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