Tony Hagen is senior managing editor for The Center for Biosimilars®.
In partnership with Samsung Bioepis, Merck has launched the trastuzumab biosimilar Ontruzant, which marks the fifth trastuzumab biosimilar available on the US market.
Under pressure from rival biosimilar manufacturers, Merck today began its US launch of the trastuzumab biosimilar Ontruzant at a 15% discount to the biologic medicine Herceptin.
The biosimilar received FDA approval more than a year ago, in January of 2019, and joins 4 other trastuzumab biosimilars now on the US market.
Ontruzant is the third trastuzumab biosimilar and the fourth biosimilar overall launched on the US market since the beginning of 2020. The launch occurs during a challenging time for pharmaceutical companies, which have had to ground field sales representatives because of the coronavirus disease pandemic and rely more heavily on digital and telecommunications to promote their products.
Pfizer and a Celltrion/Teva partnership both introduced trastuzumab biosimilars in the first quarter of this year.
Ontruzant is the 17th biosimilar to launch in the United States, which has 26 approved biosimilars.
The biosimilar is available in both 150 mg single-dose vials and 420 mg multiple-dose vials. Ontruzant was introduced at wholesaler acquisition cost (WAC) of approximately $1325 for the 150 mg single-dose vial and $3709 for the 420 mg multiple-dose vial. WACs do not include discounts to payers, providers, distributors, and other purchasing organizations.
The agent is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; as part of a treatment regimen with docetaxel and carboplatin; or as a single agent following multimodality anthracycline-based therapy.
The biosmilar was launched by Merck as part of a development and commercialization agreement with Samsung Bioepis. Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration. Under the agreement, Merck will be responsible for all commercialization activities for products approved in its partnered territories, including the United States.
On February 5, 2020, Merck announced that it intends to spin-off products from its women’s health, trusted Legacy Brands and biosimilars businesses, including Ontruzant, into a new, independent, publicly traded company. Merck will support the commercialization of the biosimilar until the spinoff, which is expected to occur in the first half of 2021, at which time Ontruzant will become a product of the new company.
The other trastuzumab biosimilars are Kanjinti, which launched in July 2019; Ogivri, December 2019; Trazimera, February 2020; and Herzuma, March 2020.