FDA Approves Herceptin Biosimilar for Breast Cancer Treatment

December 15, 2018

The FDA has approved Herzuma (trastuzumab-pkrb) (Herzuma) as a biosimilar to Herceptin (trastuzumab, Genentech). Trastuzumab-pkrb is a HER2/neu receptor antagonist indicated for the treatment of HER2-overexpressing breast cancer.

The FDA has approved Herzuma (trastuzumab-pkrb) (Herzuma) as a biosimilar to Herceptin (trastuzumab, Genentech). Trastuzumab-pkrb is a HER2/neu receptor antagonist indicated for the treatment of HER2-overexpressing breast cancer.

Common expected adverse effects of Herzuma include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough and rash. Serious expected adverse effects of Herzuma include worsening of chemotherapy-induced neutropenia.

Like Herceptin, the labeling for Herzuma contains a Boxed Warning to alert health care professionals and patients about increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity and embryo-fetal toxicity.

This article originally appeared on Specialty Pharmacy Times as "FDA Approves Herceptin Biosimilar Treatment of HER2-overexpressing Breast Cancer."


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