Merck April 15 introduced Ontruzant(trastuzumab-dttb), a biosimilar of the reference biologic medicine Herceptin, to the U.S. 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 nod- 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.
Patients are selected for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
Merck launched Ontruzant in the U.S. as part of a development and commercialization agreement with Samsung Bioepis. Under the agreement between the companies, 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.
FDA approved Ontruzant 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.
