Merck Announces US Launch of ONTRUZANT (trastuzumab-dttb), a Biosimilar of Herceptin?(trastuzumab)
APRIL 15, 2020
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. launch of ONTRUZANT (trastuzumab-dttb), as a biosimilar of the reference biologic medicine 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.
ONTRUZANT Indications and Usage
Adjuvant Breast Cancer
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 containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
- As part of a treatment regimen with docetaxel and carboplatin
- As a single agent following multimodality anthracycline-based therapy
- In combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer
- As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease
- Administration of trastuzumab products can result in subclinical and clinical cardiac failure. The incidence and severity was highest in patients receiving a trastuzumab product with anthracycline-containing chemotherapy regimens. In a pivotal adjuvant breast cancer trial, one patient who developed congestive heart failure (CHF) died of cardiomyopathy.
- Evaluate left ventricular function in all patients prior to and during treatment with ONTRUZANT. Discontinue ONTRUZANT treatment in patients receiving adjuvant therapy and withhold ONTRUZANT in patients with metastatic disease for clinically significant decrease in left ventricular function.
- Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt ONTRUZANT infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue ONTRUZANT for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.
- Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception.
- Baseline LVEF measurement immediately prior to initiation of ONTRUZANT
- LVEF measurements every 3 months during and upon completion of ONTRUZANT
- Repeat LVEF measurement at 4-week intervals if ONTRUZANT is withheld for significant left ventricular cardiac dysfunction.
- LVEF measurements every 6 months for at least 2 years following completion of ONTRUZANT as a component of adjuvant therapy.
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Media: Pamela Eisele (267) 305-3558 Michael Close (267) 305-1211 or Investor: Peter Dannenbaum (908) 740-1037 Courtney Ronaldo (908) 740-6132 Source: Merck