FDA has approved Herzuma (trastuzumab-pkrb) for injection in the same indications as the biosimilar Herceptin.
Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Celltrion Healthcare, sponsor Herzuma.
Indications include adjuvant breast cancer, metastatic breast cancer and metastatic gastric cancer. In these indications, patients should be selected for therapy based on FDA-approved companion diagnostic for a trastuzumab product.
