FDA Approves Ogivri, First Biosimilar to Herceptin

December 1, 2017

Biosimilars Team

The Food and Drug Administration (FDA) has approved Ogivri (trastuzumab-dkst; Mylan and Biocon), 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. Ogivri is the first biosimilar approved in the United States for the treatment of breast cancer or stomach cancer and only the second biosimilar approved for the treatment of cancer.

Ogivri is administered by intravenous infusion. It is approved for all eligible indications:

  • Adjuvant treatment of HER2-overexpressing node positive or node negative (EP/PR negative or with one high risk feature) breast cancer.
  • As a single agent or in combination with paclitaxel for HER2-overexpressing metastatic breast cancer.
  • 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.

Ogivri is not approved as an interchangeable product.

Similar to Herceptin, the labeling for Ogivri 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).

Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of a global settlement with Genentech and Roche earlier this year in relation to patents for Herceptin. The settlement provides Mylan with global licenses for trastuzumab-dkst.