FDA Clears New Dose of Trastuzumab Biosimilar From Samsung Bioepis

March 25, 2020

The FDA Tuesday cleared a new dose of Samsung Bioepis’ trastuzumab biosimilar Ontruzant, which is yet to be launched in the United States. The approval is for a 420-mg multidose vial of Ontruzant. The biosimilar was first approved as a 150-mg single-dose vial by the FDA in January 2019 across all indications for the reference product, Herceptin.

The FDA Tuesday cleared a new dose of Samsung Bioepis’ trastuzumab biosimilar Ontruzant, which is yet to be launched in the United States.

The approval is for a 420-mg multidose vial of Ontruzant. The biosimilar was first approved as a 150-mg single-dose vial by the FDA in January 2019 across all indications for the reference product, Herceptin.

Ontruzant is indicated for the adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease.

In the United States, Ontruzant, when launched, would compete with 4 other trastuzumab biosimilars, Herzuma, Trazimera, Ogivri, Kanjinti, as well as Herceptin.

Herzuma was launched this month and Trazimera launched last month. Ogivri launched in December 2019. Kanjinti, the first biosimilar trastuzumab to launch, in July 2019.

Samsung Bioepis said the biosimilar will be marketed and distributed in the United States by Merck, which intends to spin off products from its biosimilars business, including Ontruzant, into a new, independent, publicly traded company. This spinoff is expected to occur in the first half of 2021, and until that time Merck will handle the commercialization of Ontruzant.