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Sandoz's Biosimilar Pegfilgrastim Receives CHMP Approval for Febrile Neutropenia

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Sandoz's Biosimilar Pegfilgrastim Receives CHMP Approval for Febrile Neutropenia

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  • The CHMP approval is based on data demonstrating analytical- preclinical- and clinical information- confirming biosimilar pegfilgrastim as a reference medicine in febrile neutropenia in terms of safety- efficacy and quality
  • The biosimilar pegfilgrastim will be available in the 28 countries of EU post European Commission approval- which usually adopts CHMP positive opinion
  • Pegfilgrastim is a long-acting form of filgrastim that stimulates the production of WBCs and stem cells and Sandoz- is seeking its approval as a reference medicine for Febrile Neutropenia in EU

Ref: Sandoz | Image: Elglobal

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