ODAC Unanimously Supports Approval of First Biosimilar

January 7, 2015 10:15 PM

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In a 14-0 vote, the FDA’s Oncologic Drugs Advisory Committee (ODAC) unanimously recommended approval of EP2006, a biosimilar version of filgrastim (Neupogen; Amgen). If the FDA follows the recommendation, the drug would become the first biosimilar approved in the United States.

Filgrastim is a man-made version of granulocyte-colony stimulating factor (G-CSF), a protein that stimulates production of white blood cells known as neutrophils. When injected into the body, filgrastim has the same effect as G-CSF, increasing an individual’s ability to fight infections. With its vo...

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