FDA Approves Kanjinti, Fifth Biosimilar Trastuzumab

June 13, 2019

Biosimilars Team

The Food and Drug Administration (FDA) has approved Kanjinti (trastuzumab-anns; Amgen and Allergan), 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.

Kanjinti is the fifth trastuzumab biosimilar. Ogivri (trastuzumab-dkst; Mylan and Biocon) was approved in December 2017. Herzuma (trastuzumab-pkr; Celltrion and Teva Pharmaceutical Industries Ltd.) was approved in December 2018. Two products have been approved in 2019: Ontruzant (trastuzumab-dttb; Samsung Bioepis Co., Ltd.) was approved in January and Trazimera (trastuzumab-qyyp; Pfizer, Inc.) was approved in March. None of these biosimilars were approved as interchangeable products.

Kanjinti 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 (1) part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; (2) part of a treatment regimen with docetaxel and carboplatin; or (3) a single agent following multi-modality, anthracycline-based therapy.
  • 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 Kanjinti 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).

The full prescribing information for Kanjinti is available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761073s000lbl.pdf.