Biosimilar Labeling Dissected: Sandoz’s Zarxio Uses Amgen’s Neupogen Text

 
• By Sue Sutter

FDA took same approach with biosimilar labeling that it takes with generic drug and 505(b)(2) products, Office of New Drugs Director Jenkins says. Labeling for filgrastim-sndz contains clinical data from Neupogen label, but not Sandoz’ clinical studies.

FDA-approved labeling for Sandoz Inc.’s biosimilar Zarxio (filgrastim-sndz) resembles that of a generic small molecule and suggests that clinical studies conducted by biosimilar sponsors are unlikely to make their way into product labeling, at least in the absence of an interchangeability determination.

The labels for Zarxio and its reference product, Amgen Inc.’s granulocyte colony-stimulating factor Neupogen (filgrastim), are almost identical, save...

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