FDA approves Ontruzant, Samsung Bioepis’ Herceptin biosimilar

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FDA approves Ontruzant, Samsung Bioepis’ Herceptin biosimilar

By David Salazar - 01/21/2019
Samsung Bioepis has gained its first oncology approval in the United States for its Ontruzant (trastuzumab-dttb).

The drug is a biosimilar of Herceptin (trastuzumab) and was approved of all indications, including HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer, or gastroeseophogeal junction adenocarcinoma in treatment-naïve patients. Ontruzant will be marketed in the United States and Canada by Merck.

“For many cancer patients in the United States, battling cancer has not only been a health issue, but a considerable financial burden brought on by cancer treatment,” said Sang-Jin Park, senior vice president and head of Samsung Bioepis’ commercial division. “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.”

Ontruzant previously was approved by the European Commission in November 2017, and has launched in various European countries since then, the company said.

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