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CHMP Issues Positive Opinion on Pegfilgrastim Biosimilar

Jason Harris
Published: Friday, Sep 21, 2018

Mark Levick, MD, PhD

Mark Levick, MD, PhD
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of their biosimilar for pegfilgrastim (Neulasta), announced Sandoz, the manufacturer of filgrastim-sndz.

Sandoz is seeking an indication for their pegilgrastim biosimilar (Ziextenzo) to prevent febrile neutropenia in patients receiving myelosuppressive chemotherapy, those with acute myeloid leukemia receiving induction or consolidation chemotherapy, patients with cancer undergoing bone marrow transplantation, those undergoing autologous peripheral blood progenitor cell collection and therapy, and those with severe chronic neutropenia. These are the same proposed indications as reference pegfilgrastim.

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