> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Approves Herzuma, Biosimilar Herceptin
- URL: https://www.fdaweb.com/fda-approves-herzuma-biosimilar-herceptin/
- Published: 2019-01-02T12:00:00.000Z
- Updated: 2026-09-15T00:51:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143059

FDA has approved Celltrion’s Herzuma (transtuzumab-pkrb) as a biosimilar to Genentech’s Herceptin (transtuzumab) for patients with HER2-overexpressing breast cancer. An agency [notice](http://app.info.fda.gov/e/es?s=2027422842&e=172167&elqTrackId=78D8A052C380BCBFF284D754BEBE9730&elq=bd75345f4c23442b933c0dd53edfc8cf&elqaid=6292&elqat=1&ref=fdaweb.com) says Herzuma is a HER2/neu receptor antagonist indicated to treat HER2-overexpressing breast cancer.

The Herzuma [prescribing information](https://www.accessdata.fda.gov/drugsatfda%5Fdocs/label/2018/761091s000lbl.pdf..?ref=fdaweb.com) says common expected side effects include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash. Serious expected side effects include worsening of chemotherapy-induced neutropenia. Like Herceptin, the labeling contains a Boxed Warning for increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity.