The Food and Drug Administration (FDA) has approved Ogivri (trastuzumab-dkst; Mylan), a biosimilar to Herceptin (trastuzumab; Genentech), for the treatment of HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma.

Ogivri marks the first approved biosimilar for the treatment of breast or stomach cancer, and the second biosimilar approved for the treatment of cancer. A biosimilar is a biological product that is approved based on data demonstrating high similarity to an FDA-approved biological product (reference product) with no clinically meaningful differences in terms of safety, purity, and potency from the reference product. 

The approval of Ogivri was based on data review of its structural and functional characterization, animal study, human pharmacokinetics/pharmacodynamics, clinical immunogenicity, and other clinical safety and efficacy data that showed Ogivri was biosimilar to Herceptin. 

Common adverse effects associated with breast cancer treatment included headache diarrhea, nausea, chills, fever, infection, congestive heart failure (CHF), insomnia, cough and rash. Common adverse effects associated with gastric cancer treatment included neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss,  thrombocytopenia, mucosal inflammation, and others. 

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Ogivri, a HER2/neu receptor antagonist carries a boxed warning regarding increased risks of cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity. Ogivri is not interchangeable with Herceptin.

Ogivri will be available as a 420mg lyophilized powder in multi-dose vials for intravenous (IV) injection after reconstitution.

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