What is the difference between Ogivri and Herceptin?

Ogivri (trastuzumab-dkst), from Mylan and Biocon, is a biosimilar to Genentech's Herceptin (trastuzumab), used for the treatment of patients with HER2+ breast cancer or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). A biosimilar is a biological product that is FDA-approved and highly similar to a biologic already FDA-approved with no clinically meaningful differences in terms of safety and effectiveness from the reference product.

Is there a biosimilar approved for breast cancer?

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 overall. Like Herceptin, Ogivri is a HER2/neu receptor antagonist. Ogivri has not been approved as an interchangeable biosimilar, meaning the pharmacist cannot substitute Ogivri for Herceptin without consulting the prescriber. Note that pharmacy laws and practices vary from state to state.

What are the side effects with Ogivri?

Side effects of Ogivri can vary, but may include headache, fatigue, diarrhea, anemia, nausea, fever, infection, difficulty sleeping (insomnia), and worsening of neutropenia. Like Herceptin, the Ogivri label contains a Boxed Warning to providers and patients about increased risks of heart disease (cardiomyopathy), infusion reactions, lung damage, and harm to a developing fetus.

Learn More: What Are Biosimilars? Top Facts You May Not Know