FDA Approves Celltrion’s Trastuzumab Biosimilar

Today, the FDA approved Celltrion’s Herzuma (trastuzumab-pkrb), a biosimilar that references Genentech’s Herceptin (trastuzumab), for the treatment of patients with HER2-overexpressing breast cancer, in accordance with the FDA-approved label.  Celltrion’s product is the subject of ongoing BPCIA litigation, pending before the District of Delaware.

This marks the seventh biosimilar the FDA has approved in 2018.  The FDA previously approved Mylan’s Ogivri (trastuzumab-dkst).

Download PDF