Biosimilar approved for certain cases of breast, metastatic stomach cancer

The drug is the first FDA-approved biosimilar to treat breast or stomach cancer and the second FDA-approved biosimilar to treat cancer.


The FDA has approved a biosimilar to trastuzumab (Herceptin) for the treatment of patients with breast cancer or metastatic stomach cancer whose tumors overexpress the HER2 gene, the agency announced on Dec. 1.

The new drug, trastuzumab-dkst (Ogivri), is the first FDA-approved biosimilar to treat breast or stomach cancer and the second FDA-approved biosimilar to treat cancer. Approval was based on various clinical safety and effectiveness data demonstrating biosimilarity to trastuzumab.

Common side effects for the treatment of stomach cancer are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. Serious side effects include worsening of chemotherapy-induced neutropenia. The drug label contains a boxed warning about increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity.