Posted from: Thursday, February 07, 2019 - 05:31 PM - Present

Third Herceptin Biosimilar Approved

January 18, 2019 – The U.S. FDA has approved Ontruzant® (trastuzumab-dttb), manufactured by Samsung Bioepis, as a biosimilar to Roche’s Herceptin® (trastuzumab). It is indicated to treat HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Ontruzant will join two other Herceptin biosimilars in the U.S. market: Mylan’s Ogivri™ (trastuzumab-dkst), approved in 2017, and Teva and Celltrion’s Herzuma® (trastuzumab-pkrb), approved in 2018. As biosimilars, none of these products are automatically interchangeable with Herceptin. However, they may offer more economical treatment options for patients.

The recommended dosing for Ontruzant is based on the specific indication and individual patient factors, such as body weight. Like Herceptin and other trastuzumab biosimilars, Ontruzant carries a black box warning that describes the risk of cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo fetal toxicity.

Samsung Bioepis has not yet announced launch or pricing plans for Ontruzant. Herceptin is expected to lose exclusivity on June 18, 2019.

Last Updated Thursday, April 18, 2019 - 09:56 AM.