Questions (and a Few Answers) Arise as the FDA Approves First Biosimilar

Posted by Ed Schoonveld on Mon, Mar 16, 2015

We live in interesting times. We just saw the approval of Zarxio, the first U.S. biosimilar product of Neupogen (filgrastim). What it means for both products is still uncertain, as U.S. rules for biosimilars are still evolving. Key questions have been the convention of proprietary names for biosimilars and the interchangeability between original and biosimilar. These two questions may be an important driver of views and actions from payers and prescribers.

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