Compliance Management

FDA OKs First Biosimilar for Breast, Stomach Cancers

Dec 01, 2017

The U.S. FDA approved Mylan GmbH's Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+).

According to the FDA, Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer.

“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high cost burden for patients,” said FDA Commissioner Scott Gottlieb, M.D.

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).