Breast Cancer Biosimilar Gets FDA Approval

Jennifer Barrett, Associate Editor

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

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

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

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FDA, Division of Drug Information. FDA approves Herzuma (trastuzumab-pkrb), biosimilar to Herceptin (trastuzumab) [news release]. Silver Spring, MD; December 14, 2018: FDA website." . Accessed December 14, 2018.

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