U.S. License Holder:
Mylan / Biocon
Date of License:
FULPHILA (pegfilgrastim-jmdb) is a leukocyte growth factor indicated to:
Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Fulphila® (Mylan / Biocon) (May-2019)
Biosimilars Approved In The E.U.
Fulphila® (Mylan / Biocon) (November-2018)
Biosimilars Approved In Australia
Fulphila® (Alphapharm / Mylan / Biocon) (August-2018)
U.S. Patent LitigationsPACER
U.S. Patent Nos.
8,273,707 (Process for Purifying Proteins) 9,643,997 (Capture Purification Processes for Proteins Expressed in a Non-Mammalian System)
Amgen Inc.; Amgen Manufacturing, Ltd.
Mylan Inc.; Mylan GmbH; Mylan NV; Mylan Pharmaceuticals, Inc.
Terminated: Judgment of Non-Infringement of '707 Patent Entered; Stipulated to Non-Infringement of '997 Patent