FDA Approves Ontruzant, Third Biosimilar Trastuzumab

January 18, 2019

Biosimilars Team

The Food and Drug Administration (FDA) has approved Ontruzant (trastuzumab-dttb; Samsung Bioepis Co., Ltd.), a biosimilar to Herceptin (trastuzumab; Genentech, Inc.). Both products are monoclonal antibodies that bind selectively to the human epidermal growth factor receptor 2 protein HER2.

Ontruzant is the third trastuzumab biosimilar. Ogivri (trastuzumab-dkst; Mylan and Biocon) was approved in December 2017. Herzuma (trastuzumab-pkrb; Celltrion and Teva Pharmaceutical Industries Ltd.) was approved in December 2018. None of the three products is approved as an interchangeable product.

Ontruzant is administered by intravenous infusion. It is approved for the following indications:

  • Adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR negative or with one high-risk feature) breast cancer, as part of (1) a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel or (2) a treatment regimen with docetaxel and carboplatin.
  • In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer.
  • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one 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 an FDA-approved companion diagnostic for a trastuzumab product.

Similar to Herceptin, the labeling for Ontruzant contains a Boxed Warning to alert health care professionals and patients about increased risks of heart disease (cardiomyopathy), infusion reactions, lung damage (pulmonary toxicity), and harm to a developing fetus (embryo-fetal toxicity).

Ontruzant will be marketed and distributed in the United States by Merck.