MYLAN

FDA Approved Biologics and Pending Applications

Fulphila®

pegfilgrastim-jmdb
aBL 761075

Hulio®

adalimumab-fkjp
aBL 761154

Miacalcin®

calcitonin salmon
BL 20313 [BL 017808]

MYL-1402O

bevacizumab
MYL-1402O Approval Pending

Ogivri®

trastuzumab-dkst
aBL 761074

Semglee®

insulin glargine-yfgn
aBL 210605 / aBL 761201

Yesafili

aflibercept-jbvf
aBL 761274

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)Hulio® (adalimumab) (Mylan / Fujifilm Kyowa Kirin Biologics) (September-2018)Nepexto (etanercept) (Mylan / Lupin) (June-2020)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

Adalimumab BS (adalimumab) (Fujifilm Kyowa Kirin Biologics / Viatris / Sandoz) (June-2020)

Biosimilars Approved In South Korea

Ogivri® (trastuzumab) (Alvogen Korea) (August-2020)

Inter Partes Review Proceedings

GENENTECH CABILLYIPR2016-00710
ORENCIAIPR2015-01537
EYLEA / YESAFILIIPR2021-00880
IPR2021-00881
IPR2022-01225
IPR2022-01226
IPR2023-00099
IPR2024-00201
IPR2024-00298
HERCEPTIN / OGIVRIIPR2016-01693
IPR2016-01694
LANTUS / LANTUS SOLOSTAR / SEMGLEEIPR2017-01526
IPR2017-01528
IPR2018-01670
IPR2018-01675
IPR2018-01676
IPR2018-01677
IPR2018-01678
IPR2018-01679
IPR2018-01680
IPR2018-01682
IPR2018-01684
IPR2018-01696
IPR2019-00122
IPR2019-01657
IPR2019-01658

U.S. Patent Litigations

EYLEA / YESAFILI1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)
LANTUS / LANTUS SOLOSTAR / SEMGLEE2:17-cv-09105 (D.N.J.)
NEULASTA / FULPHILA2:17-cv-01235 (W.D. Pa.)