U.S. License Holder:
Mylan / Biocon
Date of License:
June-04-2018
Last Update:
Apr-08-2024
FDA-Approved Indications
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 Litigations
