Hospira`s Biologic Nivestym (filgrastim-aafi) Receives Approval in the U.S.
Sicor`s Biologic Granix (Tbo-filgrastim) Receives Approval in the U.S.
Kashiv BioSciences's Biologic Releuko (Filgrastim) Receives Approval in the U.S.
CuraTeQ Biologics s.r.o.'s, a wholly owned step-down subsidiary of Aurobindo Pharma Ltd, has requested to withdraw the applications for Marketing Authorization of ZEFYLTI (a filgrastim biosimilar) and DYRUPEG (a pegfilgrastim biosimilar) has been accepted by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP)
Kashiv's Biologic Releuko (Filgrastim) Receives Approval in the U.S.
PISCATAWAY, N.J.--(BUSINESS WIRE)--Kashiv Biosciences, LLC (“Kashiv”) today announced the U.S. Food and Drug Administration (FDA) approval of its Biologics License Application (BLA) for filgrastim-ayow, a biosimilar referencing Neupogen. The product will be marketed under the proprietary name RELEUKO.
BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of the Biologics License Application (BLA) for filgrastim-ayow, a biosimilar referencing Neupogen®. The product will be marketed under the proprietary name RELEUKOTM.
Kashiv Biosciences' Biologic Releuko (Filgrastim) Receives Approval in the U.S.
Tanvex BioPharma Inc (????), which focuses on supplying safe and affordable biosimilars, has obtained marketing approval in Canada for its TX01, a biosimilar of Neupogen (filgrastim), the company said yesterday.
TORONTO, Sept. 27, 2021 /CNW/ - Apobiologix, a division of Apotex Inc., expanded its leadership in Canada's biosimilar market with the approval of its first therapeutic treatment, Bambevi®. The company, a pioneer and leader in oncology biosimilars in Canada, recently received approval from Health Canada for its first therapeutic product.