Fresenius Kabi AG admits that it has become “increasingly unlikely” that a planned US Food and Drug Administration pre-approval onsite inspection for its proposed Neulasta (pegfilgrastim) biosimilar “will still actually take place” in 2021, as the FDA continues to deal with its “mounting inspection backlog.”
“COVID, unfortunately, has created unexpected uncertainty related to the timelines of these health authority reviews,” the Fresenius group’s chairman of the management board, Stephan Sturm,