Herzuma (trastuzumab-pkrb; Teva and Celltrion Healthcare), a biosimilar to Herceptin (trastuzumab; Genentech), is now available in the US for the same indications as the reference product.

Specifically, Herzuma is indicated for: 

  • Adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with 1 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; or as a single agent following multi-modality anthracycline based therapy.
  • 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 1 or more chemotherapy regimens for metastatic disease.
  • In combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

Patients should be selected for therapy based on a Food and Drug Administration (FDA)-approved companion diagnostic for a trastuzumab product. Information on tests for the detection of HER2 protein overexpression and HER2 gene amplification is available here.

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Herzuma is supplied as lyophilized powder in 150mg single-dose vials and 420mg multidose vials for reconstitution. The wholesale acquisition cost is $1402.50 for the 150mg vial and $3927 for the 420mg vial. A savings program is available for eligible commercially insured patients. 

Herzuma is not a substitute for or with ado-trastuzumab emtansine (Kadcyla; Genentech).

For more information visit Herzuma.com.