Ogivri (trastuzumab-dkst) has been approved by the U.S. Food and Drug Administration as the nation’s first biosimilar drug to treat certain breast and stomach cancers, the agency said Friday in a news release.
The maker of a biosimilar, derived from a living organism, must demonstrate that the new product is “highly similar” to an already approved medication, and that it has no clinically significant difference in terms of its potency, safety and purity, the FDA said.
Ogivri is approved to treat breast or stomach cancers attributed to a problematic HER2+ gene. The FDA said its maker, Mylan, provided sufficient evidence that the drug is biosimilar to the Genentech drug Herceptin, which was approved by the agency in 1998.
“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs,” said FDA Commissioner Dr. Scott Gottlieb. “This is especially important when it comes to a disease like cancer, that has a high cost burden for patients.”
Expected side effects for Ogivri include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough and rash, the FDA said.
Like Herceptin, Ogivri’s label will include a boxed warning about an increased risk of heart disease, serious allergic-like reactions, lung damage and harm to a developing fetus, the agency said.
Mylan is based in Canonsburg, Penn.
The FDA has more about this approval.