Samsung Bioepis Announces US Launch of Oncology Biosimilar for Early & Metastatic HER2-Overexpressing Breast Cancer & Metastatic Gastric Cancer

Samsung Bioepis Co., Ltd. recently announced today that ONTRUZANT (trastuzumab-dttb), a biosimilar of the reference biologic medicine HERCEPTIN (trastuzumab) for the treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or gastroesophageal junction adenocarcinoma, is now available in the US. Patients should be selected for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. ONTRUZANT is available in both 150-mg single-dose vials and 420-mg multi-dose vials.

The launch follows the approval from the US FDA in January 2019 for the 150-mg vial and in March 2020 for the 420-mg vial, based on Samsung Bioepis’ comprehensive data package, including analytical, nonclinical, and clinical pharmacokinetic, safety, and effectiveness data demonstrating that ONTRUZANT is highly similar to its reference product HERCEPTIN, and there are no clinically meaningful differences in terms of the safety, purity and potency of the product.

“The launch of ONTRUZANT to deliver our first oncology biosimilar in the US marks an important milestone for Samsung Bioepis, and more importantly, for the patients who are in need of this proven treatment,” said Christopher Ko, President and Chief Executive Officer, Samsung Bioepis. “While we understand that this is an unprecedented time for our hospitals and healthcare workers, we at Samsung Bioepis remain steadfastly committed to the patients we serve through our efforts to ensure the continued supply of our medicines through collaboration with our manufacturing and commercial partners.”

ONTRUZANT will be introduced in the US 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 will be marketed and distributed in the US by Merck (known as MSD outside the US and Canada), which announced on February 5, 2020, that it intends to spin-off certain products, amongst them ONTRUZANT and its biosimilars businesses, into a new, independent, publicly-traded company. Merck will continue to fully support the commercialization of ONTRUZANT until the spin-off, which is intended to take place in the first half of 2021, at which time ONTRUZANT will become a product of the new company.

Under terms of agreement, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration while Merck is responsible for commercialization activities for products approved in its partnered territories, including the US.

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 multi-modality anthracycline-based therapy

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product

* High-risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

ONTRUZANT is indicated:

-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

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product

ONTRUZANT is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, visit www.samsungbioepis.com.