Fresenius Kabi Concedes On FDA Pegfilgrastim Chances

German Firm Also Rules Out Humira Interchangeability Designation

 
• By Dean Rudge

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.

Washington, D.C., USA- January 13, 2020: FDA Sign outside their headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
The FDA is working on barriers to inspections • Source: Shutterstock

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,

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