FDA approves Ziextenzo (pegfilgrastim-bmez), 3rd biosimilar to Neulasta (pegfilgrastim)

FDA approves Ziextenzo (pegfilgrastim-bmez), 3rd biosimilar to Neulasta (pegfilgrastim)

The U.S. Food and Drug Administration (FDA) today approved Ziextenzo (pegfilgrastim-bmez) , a biosimilar to U.S.-licensed Neulasta (pegfilgrastim).

A biosimilar is a biological product that is highly similar to an existing FDA-approved biological product, known as a reference product. The biosimilar must also have no clinically meaningful differences in terms of safety and effectiveness from the reference product. For more information about biosimilar products, visit www.fda.gov/biosimilars.