CHMP Issues Positive Opinion on Pegfilgrastim Biosimilar

September 21, 2018 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of filgrastim-sndz, a biosimilar for Amgen’s pegfilgrastim, announced Sandoz, the manufacturer of filgrastim-sndz. Sandoz is seeking an indication for filgrastim-sndz to prevent febrile neutropenia in patients receiving myelosuppressive chemotherapy, those with acute myeloid leukemia receiving induction or consolidation … (leggi tutto)