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FDA Approves First Biosimilar

Sandoz Zarxio approved for all indications on Filgrastim label

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By: Kristin Brooks

Managing Editor, Contract Pharma

Sandoz, a Novartis company, received approval from the FDA for Zarxio a biosimilar of filgrastim (Amgen’s Neupogen) for all indications included in the reference product’s label. Sandoz is the first company to receive approval of a biosimilar in the U.S. through the new biosimilars pathway established under the Biologics Price Competition and Innovation Act.     The approval was based on analytical, nonclinical, and clinical data, confirming that Zarxio is highly similar to the U.S.-licensed ref...

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