Sandoz Tries Again With US Pegfilgrastim

Sandoz has resubmitted its application for biosimilar pegfilgrastim to the FDA, having been knocked back with a complete response letter in 2016.

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Sandoz Is Making Another Attempt With Its US Pegfilgrastim Biosimilar • Source: Shutterstock

Sandoz has refiled its application for biosimilar pegfilgrastim with the US Food and Drug Administration (FDA), nearly three years after the firm was knocked back by a complete response letter (CRL) in June 2016 for its initial application.

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