FDA Approves Samsung Bioepis’s Trastuzumab Biosimilar

Today, the FDA approved Samsung Bioepis’s Ontruzant (trastuzumab-dttb), a biosimilar to Genentech’s Herceptin (trastuzumab), for the treatment of patients with HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.  Samsung Bioepis’s product is the subject of ongoing BPCIA litigation, pending before the District of Delaware.

This is the third biosimilar of trastuzumab to receive FDA approval.  The FDA previously approved Celltrion’s Herzuma (trastuzumab-pkrb) and Mylan’s Ogivri (trastuzumab-dkst).