Merck announces US launch of ONTRUZANT, a biosimilar of Herceptin

ONTRUZANT is available in both 150 mg single-dose vials and 420 mg multiple-dose vials.

ONTRUZANT will be introduced in the U.S. at a list price (wholesaler acquisition cost) of approximately $1,325 for the 150 mg single-dose vial and $3,709 for the 420 mg multiple-dose vial (prices are rounded), representing a 15% discount to the current list price of Herceptin. Wholesaler acquisition costs do not include discounts to payers, providers, distributors and other purchasing organizations.

ONTRUZANT is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) 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; as a single agent following multi-modality anthracycline based therapy. Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Serious and sometimes fatal side effects have been reported with trastuzumab products. Subclinical and clinical cardiac failure have been reported. The incidence and severity were highest in patients receiving trastuzumab with anthracycline-containing regimens. Discontinue ONTRUZANT treatment for cardiomyopathy. Administration of ONTRUZANT can result in serious and fatal infusion reactions and pulmonary toxicity. Discontinue ONTRUZANT for anaphylaxis, angioedema, interstitial pneumonitis or acute respiratory distress syndrome. Exposure to ONTRUZANT during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Exacerbation of chemotherapy-induced neutropenia can also occur. Detection of HER2 protein overexpression is necessary for selection of patients appropriate for ONTRUZANT therapy.

ONTRUZANT is being launched in the U.S. by Merck as part of a development and commercialization agreement with Samsung Bioepis. Under terms of the agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration. Merck will be responsible for all commercialization activities for products approved in its partnered territories, including the U.S.

ONTRUZANT was approved by the FDA in January 2019 based on the review of Samsung Bioepis’ comprehensive data package, which included extensive structural and functional analytical data, nonclinical and clinical pharmacokinetic data, and a comparative clinical study demonstrating that ONTRUZANT is highly similar to its reference product, Herceptin, in terms of the safety, purity and potency of the product.
On Feb. 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 continue to fully support the commercialization of ONTRUZANT until the spinoff, which is intended to take place in the first half of 2021, at which time ONTRUZANT will become a product of the new company.

Source: Company Press Release