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Home » FDA Approves Amneal’s Avastin Biosimilar
FDA Approves Amneal’s Avastin Biosimilar
April 20, 2022
The FDA has approved Amneal Pharmaceuticals’ Alymsys (bevacizumab-maly) as a biosimilar of Roche’s blockbuster cancer drug Avastin.
The biosimilar was developed by mAbxience and licensed to Roche’s subsidiary Genentech in 2018 for supplying to the U.S. market.
This is Amneal’s second biosimilar approval in 2022. The FDA approved Releuko (filgrastim-ayow), its biosimilar of Amgen’s white blood-cell booster Neupogen (filgrastim) earlier this year. And the agency is currently reviewing the company’s biosimilar of another Amgen bone marrow stimulant drug, Neulasta (pegfilgrastim).
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