On December 1, 2017, the US Food and Drug Administration (FDA) approved Ogivri (trastuzumab-dkst, Mylan) as a biosimilar to Herceptin (trastuzumab, Genentech, Inc.) for the treatment of patients with HER2-overexpressing breast or metastatic gastric or gastro-esophageal junction adenocarcinoma.

The drug is the first biosimilar approved in the US for the treatment of breast cancer or gastric cancer and the second FDA-approved biosimilar for the treatment of cancer.

Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

Approval was based on comparisons of extensive structural and functional product characterization, animal data, human pharmacokinetic and pharmacodynamic data, and clinical studies including clinical immunogenicity between Ogivri and US-licensed Herceptin. These data demonstrate that Ogivri is highly similar to US-licensed Herceptin and that there are no clinically meaningful differences between the products.

Ogivri has been approved as a biosimilar, not as an interchangeable product.

Common expected side effects of Ogivri for the treatment of HER2-positive breast cancer include headache, diarrhea, nausea, chills, fever, infection, congestive heart failure, insomnia, cough, and rash.

Common expected side effects of Ogivri for the treatment of HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma include neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.

Serious expected side effects of Ogivri include worsening of chemotherapy-induced neutropenia.

Like Herceptin, the labeling for Ogivri contains a Boxed Warning to alert health care professionals and patients about increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity.