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# FDA Approves Mylan’s Herceptin Biosimilar
- URL: https://www.fdaweb.com/fda-approves-mylans-herceptin-biosimilar/
- Published: 2017-12-01T12:00:00.000Z
- Updated: 2026-09-14T23:04:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140244

FDA has approved Mylan’s Ogivri (trastuzumab-dkst), the first biosimilar to Genentech’s Herceptin, indicated for treating patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors over-express the HER2 gene. Ogivri is the first biosimilar approved in the U.S. for breast or stomach cancer.  

[FDA says](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587378.htm?ref=fdaweb.com) it based the approval on an evidence review that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrated biosimilarity. The agency notes that the approval does not cover s interchangeability.

Common side effects expected for Ogivri include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, difficulty sleeping, cough and rash. “Like Herceptin, the labeling for Ogivri contains a Boxed Warning to alert health care professionals and patients about increased risks of heart disease (cardiomyopathy), infusions reactions, lung damage (pulmonary toxicity) and harm to a developing fetus (embryo-fetal toxicity),” FDA says.