Ogivri Launched as Herceptin Biosimilar

December 2, 2019 – Mylan and Biocon have announced the launch of OgivriTM (trastuzumab-dkst), a biosimilar for Roche’s Herceptin® (trastuzumab). It is the second Herceptin biosimilar to be launched on the U.S. market. The first was Amgen’s KanjintiTM (trastuzumab-anns), which launched in June 2019.

Like Herceptin and Kanjinti, Ogivri is approved to treat HER2-overexpressing breast cancer and HER2- overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. In HER2-overexpressing cancers, a genetic mutation causes excess production of a protein known as human epidermal growth factor receptor 2 (HER2). The overabundance of HER2 can lead to more aggressive growth of cancer cells. Trastuzumab products specifically target this mutation by blocking HER2/neu receptors, which can help to inhibit cancer cell growth.

Recommend dosing with Ogivri is based on the diagnosis being treated. A black box warning cautions that there is a risk of cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity with all trastuzumab products. As a biosimilar, Ogivri is not considered automatically interchangeable with Herceptin or with Kanjinti.

Ogivri first received FDA approval in December 2017. It is available in 420mg vials at a wholesale acquisition cost (WAC) of $3,697.26 per vial, and in 150mg vials at a WAC of $1,324.66 per vial. Ogivri's WAC is 15% less than Herceptin's.