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FDA approves third Herceptin biosimilar with Samsung Bioepis' Ontruzant

Published on 22/01/19 at 11:26am

Samsung Bioepis’ has announced that the FDA has chosen to approve Ontruzant (trastuzumab-dttb), its biosimilar version of Roche’s Herceptin (trastuzumab), in the same indications as its reference product.

This includes three cancer indications: as an 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.

The decision marks the first approval of an oncology biosimilar for Samsung Bioepis. The therapy secured approval in Europe in November last year. Ontruzant now joins Mylan’s Ogivri and Celltrion’s Herzuma as the third Herceptin biosimilar approved in the US.

“For many cancer patients in the US, battling cancer has not only been a health issue, but a considerable financial burden brought on by cancer treatment,” commented Sang-Jin Pak, Senior Vice President and Head of Commercial Division at Samsung Bioepis. “Biosimilars are intended to be lower cost, high-quality treatment options that have the potential to alleviate such burden. We sincerely hope our trastuzumab biosimilar will do exactly that.”

Matt Fellows

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