Third Trastuzumab Biosimilar Granted FDA Approval

JANUARY 18, 2019
Officials with the FDA have approved Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer and HER2 overexpressing gastric cancer.

The drug was first approved by the European Medicines Agency in November 2017, making the it the first biosimilar trastuzumab to be approved in the European Union. Since the approval, Europe has also seen the entry of 3 additional versions of biosimilar trastuzumab: Herzuma, Kanjinti, and Ogivri. The United States' FDA accepted Samsung Bioepis' Biologics License Application for Ontruzant in December 2017.

To gain FDA approval, a biosimilar must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. Ontruzant is the first biosimilar to receive approval in 2019. Last year, the FDA approved a total of 7 biosimilars. 

Samsung Bioepis presented safety and efficacy study results for the biosimilar at 1 year in an abstract at the 2018 San Antonio Breast Cancer Symposium, held in San Antonio, Texas, from December 4 to 8, 2018. The study evaluated patients with HER2-positive early breast cancer or locally advanced breast cancer who were randomized to receive either the biosimilar or its reference concurrently with chemotherapy.

This article was adapted from our sister publication The Center for Biosimilars. View the full version at