FDA approves Herzuma (trastuzumab biosimilar) for breast cancer.- Celltrion + Teva.

Celltrion and Teva Pharmaceutical announced that the FDA has approved Herzuma (trastuzumab-pkrb), a HER2/neu receptor antagonist biosimilar to Herceptin (trastuzumab) for the following indications: Adjuvant Breast Cancer of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer; as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; as part of a treatment regimen with docetaxel and carboplatin; Metastatic Breast Cancer: in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer; as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease. In these indications, patients should be selected for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

The FDA approval is based on a review of a comprehensive data package inclusive of foundational analytical similarity data, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy and safety data. The results of the clinical development program for Herzuma demonstrated that there were no clinically meaningful differences in purity, potency and safety between Herzuma and Herceptin for the treatment of HER2-overexpressing breast cancer for the approved indications.