Posted by Michael Wonder on 24 May 2020
Fresenius Kabi’s regulatory submission for pegfilgrastim biosimilar accepted for review by EMA
22 May 2020 - Fresenius Kabi announced today that the EMA has accepted for review the company’s marketing authorisation application for MSB11455, a biosimilar candidate of Neulasta (pegfilgrastim).
MSB11455 is a molecule that stimulates the growth of certain white blood cells which are essential to fight infections, a common event in patients with cancer receiving chemotherapy.
MSB11455 was developed by Fresenius Kabi’s biosimilars team based in Switzerland.
