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FDA Recently Approved Herzuma, a Biosimilar to Herceptin

Herzuma (trastuzumab-pkrb), an engineered biologic medication that is a “biosimilar” to Herceptin, was recently approved by the U.S. Food & Drug Administration. Herzuma was approved for use in patients with HER2+ breast cancer, to be used either alone or in combination with other medicines. HER2+ breast cancer is characterized by tumors that overproduce a specific molecule known as human epidermal growth factor receptor-2, or HER2.1

Herzuma can be used against metastatic breast cancer or as adjuvant therapy after initial breast cancer treatment.1 Metastatic breast cancer refers to advanced breast cancer that has already spread to other parts of the body. Adjuvant therapy keeps cancer from recurring after initial treatment, like surgery.2

Herzuma is a monoclonal antibody, which is a type of targeted therapy. Certain breast cancer cells have large numbers of molecules called human epidermal growth factor receptor-2, or HER2, on their cell surfaces. These molecules stimulate abnormally fast cell growth. Like Herceptin, Herzuma binds to and blocks these molecules, also killing the cancerous cells that carry them.3

What is a biosimilar?

A biosimilar is a product that is highly similar to an already approved product. Biosimilars are not the same as generics, which have the same active ingredient and are equivalent copies of a reference medicine. However, biosimilars must undergo a thorough evaluation to ensure their safety and effectiveness before they receive approval, demonstrating no clinically meaningful differences from the approved reference product. Biosimilar medications are approved based on the similarity of their action to approved medications.4

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