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.”
Fresenius Kabi Concedes On FDA Pegfilgrastim Chances
German Firm Also Rules Out Humira Interchangeability Designation
Fresenius Kabi is continuing to suffer from the longstanding effects of the US FDA backlog for onsite inspection reviews amid the coronavirus pandemic. Management discussed Kabi’s latest prospects on its proposed pegfilgrastim biosimilar, as well as adalimumab and tocilizumab.
