Merck Launches ONTRUZANT® (trastuzumab-dttb), a Herceptin® Biosimilar, in the U.S.

Compiled by S.Li

On April 15, local time, Merck & Co., Inc. (MSD) announced the launch of Ontruzant (trastuzumab) in the United States. This medication is a biosimilar to Roche’s branded drug Herceptin (generic name: trastuzumab) and is indicated for all indications approved for Herceptin, including HER2-positive early breast cancer, HER2-positive metastatic breast cancer, and HER2-positive metastatic gastric cancer (adenocarcinoma of the stomach or gastroesophageal junction).

It is reported that the wholesale price of Ontruzant in the United States is approximately 15% lower than that of the originator drug, specifically priced at $1,325 for the 150 mg strength and $3,709 for the 420 mg strength. This pricing is comparable to other Herceptin biosimilars already marketed in the United States.

Ontruzant was co-developed by MSD and Samsung Bioepis, with Samsung Bioepis responsible for research, development, and manufacturing, and MSD responsible for commercialization. Based on comprehensive structural and functional analyses, preclinical studies, clinical pharmacokinetic studies, and comparative clinical trial data provided by Samsung Bioepis, Ontruzant demonstrated high similarity to the reference product Herceptin in terms of purity, safety, and efficacy.

Ontruzant was first approved by the European Union in late November 2017, becoming the first trastuzumab biosimilar approved for marketing in the European market. In the United States, Ontruzant received FDA approval for marketing in January 2019.It is the third trastuzumab biosimilar approved in the United States, following Mylan/Biocon’s Ogivri (approved in December 2017) and Celltrion/Teva’s Herzuma (approved in December 2018).

Roche’s patent for the originator drug Herceptin expired in the United States in June 2019. Currently, five biosimilars of Herceptin have been approved in the U.S. market; in addition to the three aforementioned products, these include Pfizer’s Trazimera (approved in March 2019) and Amgen and Allergan’s Kanjinti (approved in June 2019). Among them,Kanjinti, Ogivri, and Herzuma have all been launched and are commercially available.

In February, MSD announced that it would spin off its Women's Health, Legacy Brands, and Biosimilars businesses (including Ontruzant), with plans to establish a new company to manage these operations. However, until the spin-off is completed, MSD will continue to fully support the commercialization of Ontruzant.

Reference Sources

1、Merck Announces US Launch of ONTRUZANT® (trastuzumab-dttb), a Biosimilar of Herceptin® (trastuzumab)

2、Merck, Samsung join newly crowded market for Herceptin biosimilars