Herzuma Approved as Biosimilar to Herceptin

December 14, 2018 – The U.S. FDA has approved Herzuma® (trastuzumab-pkrb), manufactured by Celltrion and Teva, as a biosimilar to Genentech’s Herceptin® (trastuzumab). It is indicated to treat HER2-overexpressing breast cancer, as verified by an FDA-approved companion diagnostic test.

For adjuvant breast cancer, Herzuma should be used as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, or as part of a treatment regimen with docetaxel and carboplatin. For metastatic breast cancer, it should be used in combination with paclitaxel (for first-line treatment) or as a single agent in patients who have received one or more chemotherapy regimens for metastatic disease.

Recommended dosing is based on the indication, with both adjuvant and metastatic breast cancer requiring an initial dose of 4 mg/kg delivered via intravenous (IV) infusion over the course of 90 minutes. A black box warning cautions that Herzuma may cause cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity.

As a biosimilar, Herzuma is not automatically interchangeable with Herceptin, though it does provide patients with an alternative therapy. Herceptin was first approved by the FDA in 1998.

Launch and pricing plans have not yet been announced.