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

On May 22, 2020 Fresenius reported that the European Medicines Agency (EMA) has accepted for review Fresenius Kabi`s Marketing Authorization Application (MAA) for MSB11455, a biosimilar candidate of Neulasta (pegfilgrastim)* (Press release, Fresenius, MAY 22, 2020, View Source [SID1234558408]). This is another milestone for Fresenius Kabi following last year`s approval and launch of the company`s adalimumab biosimilar (Idacio) in Europe. (* Neulasta is a registered trademark of Amgen)

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