Posted by Michael Wonder on 29 May 2020
FDA accepts for review Fresenius Kabi’s first biosimilar regulatory submission for MSB11455, a biosimilar candidate of pegfilgrastim
27 May 2020 - Fresenius Kabi announced today that the U.S. FDA has accepted for review the company’s biologics license application for MSB11455, a biosimilar candidate of Neulasta (pegfilgrastim).
This application represents Fresenius Kabi’s first biosimilar candidate submitted to the FDA. Dr. Michael Schönhofen, Member of the Fresenius Kabi Management Board and President of the Pharmaceuticals and Devices Division, said: “This is an important achievement in the development of our biosimilar pipeline in the US.
We continue to expand our portfolio to deliver high-quality and affordable therapies, a vital need in the treatment of cancer and other life-threatening diseases.”
