FDA Approved Biologics and Pending Applications
denosumab
Bmab 1000 Approval Pending
pegfilgrastim-jmdb
aBL 761075
adalimumab-fkjp
aBL 761154
insulin human
Insulin-R Approval Pending
bevacizumab-nwgd
aBL 761175
insulin aspart
MYL-1601D Approval Pending
trastuzumab-dkst
aBL 761074
insulin glargine-yfgn
aBL 210605 / aBL 761201
aflibercept-jbvf
aBL 761274
ustekinumab-kfce
aBL 761406
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Abevmy (bevacizumab) (Biocon / Viatris) (November-2021)Fulphila® (pegfilgrastim) (Mylan / Biocon) (May-2019) Kirsty (BGP Pharma (Viatris)) (October-2021)Ogivri® (trastuzumab) (Mylan / Biocon) (May-2019)Yesafili (aflibercept) (Biocon) (June-2025)
Biosimilars Approved In The E.U.
Abevmy (bevacizumab) (Biocon / Viatris) (April-2021)Fulphila® (pegfilgrastim) (Mylan / Biocon) (November-2018)Kirsty (previously Kixelle) (insulin aspart) (Viatris / Biocon) (February-2021)Ogivri® (trastuzumab) (Mylan / Biocon) (December-2018)Semglee® (insulin glargine) (Mylan / Biocon) (March-2018)Yesafili (aflibercept) (Biocon) (EU: September-2023; UK: November-2023)
Biosimilars Approved In Australia
Fulphila® (pegfilgrastim) (Alphapharm / Mylan / Biocon) (August-2018)Ogivri® (trastuzumab) (Mylan / Biocon) (December-2018) Semglee® (insulin glargine) (Mylan / Biocon) (March-2018)
Biosimilars Approved In Japan
Insulin glargine BS (insulin glargine) (Biocon / Fujifilm Pharma) (March-2016)
Biosimilars Approved In South Korea
Ogivri® (trastuzumab) (Alvogen Korea) (August-2020)
Inter Partes Review Proceedings
GENENTECH CABILLYIPR2016-00710EYLEA / YESAFILIIPR2024-00201IPR2024-00298LANTUS / LANTUS SOLOSTAR / SEMGLEEIPR2017-01526IPR2017-01528IPR2018-01670IPR2018-01675IPR2018-01676IPR2018-01677IPR2018-01678IPR2018-01679IPR2018-01680IPR2018-01682IPR2018-01684IPR2018-01696IPR2019-00122IPR2019-01657STELARA / YESINTEKIPR2023-01444
U.S. Patent Litigations
EYLEA / YESAFILI1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)PROLIA / XGEVA / BMAB 10001:25-cv-11867 (D. Mass.)
