Fresenius Kabi’s regulatory submission for pegfilgrastim biosimilar accepted for review by FDA

Fresenius Kabi announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company`s Biologics License Application (BLA) for MSB11455, a biosimilar candidate of Neulasta® (pegfilgrastim)*. This is an important achievement in the development of Fresenius Kabi’s biosimilar pipeline in the US. Fresenius Kabi also received acceptance for review of its regulatory submission for its pegfilgrastim biosimilar candidate from the European Medicines Agency this month. (* Neulasta® is a registered trademark of Amgen)

The release as fetched from its publisher. fresenius.com ↗