The Food and Drug Administration (FDA) has approved Ontruzant (trastuzumab-dttb; Samsung Bioepis), a biosimilar to Herceptin (trastuzumab; Genentech).

Ontruzant, a HER2/neu receptor antagonist, is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with 1 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; or as a single agent following multi-modality anthracycline based therapy. In addition, it is approved for use in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer, and as a single agent, for treatment of HER2-overexpressing breast cancer in patients who have received 1 or more chemotherapy regimens for metastatic disease.

Ontruzant is also approved for use 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.

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“Biosimilars are intended to be lower cost, high-quality treatment options that have the potential to alleviate [financial] burden,” said Sang-Jin Pak, Senior Vice President and Head of Commercial Division, Samsung Bioepis. “We sincerely hope our trastuzumab biosimilar will do exactly that.”


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Ontruzant  is supplied as 150mg lyophilized powder in a single-dose vial for reconstitution. Prior to treatment, HER2 testing using FDA-approved tests should be performed. The product should not be substituted for or with ado-trastuzumab emtansine.

For more information visit samsungbioepis.com