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How To Label A Biosimilar? Copy The Reference Product, FDA Told Sandoz

 
• By Sue Sutter

But agency had to weigh how presentation differences between Sandoz’s Zarxio and Amgen’s Neupogen, as well as Neupogen-specific safety information, should be reflected in the biosimilar’s labeling.

FDA had to weigh whether and how differences in the presentations of Sandoz Inc.’s Zarxio (filgrastim-sndz) and its reference product, Amgen Inc.’s Neupogen (filgrastim), should be reflected in biosimilar labeling that was otherwise highly “generic-like” in approach.

Review documents show the agency advocated early on for the Neupogen label to serve as the model for Zarxio’s prescribing...

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