Teva Pharmaceutical Industries Ltd. and Celltrion Inc. said the U.S. Food and Drug Administration approved Herzuma, a biosimilar version of Roche Holding AG's blockbuster breast cancer medicine Herceptin.
The regulator approved Herzuma, or trastuzumab-pkrb, to treat breast cancer in patients with a mutation of the human epidermal growth factor receptor 2, or HER2 gene. The approval means the biosimilar can be used in combination with chemotherapy paclitaxel as a first-line therapy for breast cancer that has spread to other parts of the body.
The companies said patients should be selected for therapy based on an FDA-approved diagnostic test, similar to patients who receive Herceptin, or trastuzumab, for determining the applicability of the medicine.
The companies added that trastuzumab products carry boxed warnings of cardiomyopathy, a disease of the heart muscle; a lung disease called pulmonary toxicity; and embryo-fetal toxicity.
The FDA approval was based on data for Herzuma which showed no clinically meaningful differences in purity, potency and safety between the biosimilar and Herceptin.
Earlier in April, the FDA rejected South Korean drugmaker Celltrion's application to gain marketing approval for Herzuma and Truxima, a biosimilar of another Roche drug — MabThera, based on a warning letter issued related to manufacturing processes at the company's manufacturing plant in Incheon.
Israel-based Teva has exclusive rights to commercialize Herzuma in the U.S. and Canada.