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

The European Medicines Agency (EMA) has accepted for review Fresenius Kabi`s Marketing Authorization Application (MAA) for MSB11455, a biosimilar candidate of Neulasta® (pegfilgrastim)*. 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)

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