Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Fulphila® (pegfilgrastim) (Mylan / Biocon) (May-2019) Ogivri (trastuzumab) (Mylan / Biocon) (May-2019)
Biosimilars Approved In The E.U.
Fulphila® (pegfilgrastim) (Mylan / Biocon) (November-2018)Ogivri (trastuzumab) (Mylan / Biocon) (December-2018)Semglee (insulin glargine) (Mylan / Biocon) (March-2018)
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)
Inter Partes Review Proceedings
GENENTECH CABILLYIPR2016-00710LANTUS / LANTUS SOLOSTAR / SEMGLEEIPR2017-01526IPR2017-01528IPR2018-01670IPR2018-01675IPR2018-01676IPR2018-01677IPR2018-01678IPR2018-01679IPR2018-01680IPR2018-01682IPR2018-01684IPR2018-01696IPR2019-00122
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