Merck Announces US Launch of Trastuzumab Biosimilar

April 15, 2020

Merck has announced the US launch of trastuzumab-dttb (Ontruzant), a biosimilar to trastuzumab (Herceptin), in both 150-mg single-dose vials and 420-mg multiple-dose vials.

Merck has announced the US launch of trastuzumab-dttb (Ontruzant), a biosimilar to trastuzumab (Herceptin), in both 150-mg single-dose vials and 420-mg multiple-dose vials, according to a company release.1

Trastuzumab is indicated for the adjuvant treatment of human epidermal growth factor receptor 2-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.

Trastuzumab-dttb was approved by the FDA in January 2019 based on the review of Samsung Bioepis’ comprehensive data package demonstrating that the biosimilar is highly similar to its reference product. The FDA subsequently approved a 420-mg multi-dose of trastuzumab-bttb in March 2020.

According to Merck, trastuzumab-dttb is being launched in the United States as part of a development and commercialization agreement with Samsung Bioepis. Trastuzumab-dttb will be available in the United States at a list price of approximately $1325 for the 150-mg single-dose vial and $3709 for the 420-mg multiple-dose vial, representing a 15% discount to the current list price of Herceptin.

There are currently 5 trastuzumab biosimilars approved by the FDA, according to the agency.2

References:

1. Merck Announces US Launch of Ontruzant (trastuzumab-dttb), a Biosimilar of Herceptin (trastuzumab). News Release. Merck; April 15, 2020. Accessed April 15, 2020. https://www.mrknewsroom.com/news-release/prescription-medicine-news/merck-announces-us-launch-ontruzant-trastuzumab-dttb-biosimi.

2. Biosimilar Product Information. FDA; Updated February 24, 2020. Accessed April 15, 2020. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information.