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

On May 27, 2020 Fresenius Kabi reported 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)* (Press release, Fresenius, MAY 27, 2020, View Source [SID1234558523]). 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)

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