U.S. Food and Drug Administration Approves Pegfilgrastim-bmez (Ziextenzo) for Long-Acting Oncology Supportive Care

On November 5, 2019, the U.S. Food and Drug Administration (FDA) announced it has approved the use of pegfilgrastim-bmez (Ziextenzo, Sandoz), a long-lasting supportive care biosimilar to pegfilgrastim (Neulasta, Amgen). Pegfilgrastim-bmez (Ziextenzo, Sandoz) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever) for patients with nonmyeloid malignancies who are receiving myelosuppressive anti-cancer therapy.

A biosimilar is a biological product that is highly similar to and has no clinically meaningful difference from an existing FDA-approved biological productor, or reference product.

Biosimilars must have no clinically meaningful differences from their reference products regarding safety and effectiveness.  Only small differences in clinically inactive components are allowable with biosimilar products.

The U.S. Congress, through the Biologics Price Competition and Innovation Act of 2009, created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved biological product. FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. These standards may be viewed on the FDA website.

For more information on the FDA approval of Pegfilgrastim-bmez (Ziextenzo), visit the FDA’s website.

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Chemotherapy halts cell growth and division to prevent cancer cells from making more and more cancer cells. The purpose of chemotherapy is to kill cancer cells. It is usually used to treat cancer when it is systemic, meaning that the cancer has spread throughout the body. Learn more >