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Fresenius Kabi Awaits EMA Inspection For Pegfilgrastim Biosimilar

Facing Greater Challenge For FDA Approval

 
• By Dean Rudge

Having recently announced plans to launch a further four biosimilar products in the next four years, Fresenius Kabi has disclosed the latest on its bid to introduce pegfilgrastim, which has been hamstrung in the US by delayed inspections.

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Fresenius Kabi aims to launch pegfilgrastim in the EU and US next year • Source: Alamy

Fresenius Kabi expects to launch its pegfilgrastim biosimilar, Stimufend, in the EU “early next year” after revealing plans for a European Medicines Agency inspection by the end of the summer, although the US is proving a tricker prospect with COVID-19 related delays continuing to hinder US Food and Drug Administration inspections.

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Coherus Marks Exit From Biosimilars By Completing Udenyca Divestment

 
• By Dave Wallace

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