Fresenius Kabi Files EU Pegfilgrastim
‘Milestone’ Biosimilar Submission Comes Ahead Of Planned Launch In 2021
Fresenius Kabi’s biosimilar pegfilgrastim rival to Neulasta has been accepted for review by the European Medicines Agency. The firm believes the “milestone” application will pave the way for a 2021 launch.
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Fresenius Kabi is looking to make headway into biosimilars but saw its progress limited by COVID-19 in Q2. Management gave an update on the company’s endeavors during the Q2 earnings call, including key tender victories.
Pfizer has won the first US Food and Drug Administration biosimilar approval this year, for its Nyvepria (pegfilgrastim-apgf) pre-filled syringes. However, it must overcome intellectual property hurdles before it can roll out the product.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.