Samsung Bioepis Announces FDA Approval of 420 mg Multi-dose Vial of ONTRUZANT

Samsung Bioepis announced the U.S. Food and Drug Administration (FDA) has approved a 420 mg multi-dose vial of ONTRUZANT® (trastuzumab-dttb), a biosimilar referencing HERCEPTIN® (trastuzumab).

ONTRUZANT® was first approved as a 150 mg single-dose vial by FDA in January 2019 across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease.

ONTRUZANT® will be marketed and distributed in the United States by Merck which announced on February 5, 2020, that it intends to spin-off products from its biosimilars businesses, including ONTRUZANT®, into a new, independent, publicly-traded company. Merck will continue to 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® 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
• 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.

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