BRIEF—FDA approves Herzuma biosimilar to Herceptin

The US Food and Drug Administration approved Herzuma (trastuzumab-pkrb) from South Korean firm Celltrion, as a biosimilar to Herceptin (trastuzumab), marketed by Roche subsidiary Genentech, for patients with HER2-overexpressing breast cancer.

Herzuma is a HER2/neu receptor antagonist indicated for the treatment of HER2-overexpressing breast cancer.

Common expected side effects of Herzuma for the treatment of HER2+ breast cancer include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash. Serious expected side 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.