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# Celltrion BLA for Herceptin Biosimilar
- URL: https://www.fdaweb.com/celltrion-bla-for-herceptin-biosimilar/
- Published: 2018-12-14T12:00:00.000Z
- Updated: 2026-09-15T00:51:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143048

FDA has approved a Celltrion BLA for Herzuma (trastuzumab-pkrb) as a biosimilar to Genentech’s Herceptin (trastuzumab) for patients with HER2-overexpressing breast cancer. Common adverse events 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, an [FDA release](http://app.info.fda.gov/e/es?s=2027422842&e=172160&elqTrackId=78D8A052C380BCBFF284D754BEBE9730&elq=16078c4e66504d2098c10118ad4a29b5&elqaid=6292&elqat=1&ref=fdaweb.com) says. Like Herceptin, Herzuma’s labeling contains a Boxed Warning to alert health care professionals and patients about increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity.