U.S. License Holder:
Tanvex BioPharma, Inc.
Date of License:
BLA submitted to FDA October-2018, CRL September-2019; Resubmission November-2020, CRL May-2021
TX-01 (filgrastim) is not FDA-approved. A BLA has been submitted to the FDA.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Nypozi (Tanvex Biopharma USA) (October-2021)
U.S. Patent LitigationsPACER
U.S. Patent Nos.
9,856,287 (Refolding Proteins Using a Chemically Controlled Redox State)
Amgen Manufacturing, Ltd.; Amgen Inc.
Tanvex Biologics Corp.; Tanvex Biopharma, Inc.; Tanvex BioPharma USA, Inc.