FDA Approved Biologics and Pending Applications
lixisenatide
BL 208471
insulin lispro recombinant
aBL 209196
insulin glulisine recombinant
BL 021629
rasburicase
BL 103946
sarilumab
BL 761037
insulin glargine recombinant
BL 021081
alirocumab
BL 125559
isatuximab-irfc
BL 761113
insulin glargine; lixisenatide
BL 208673
insulin glargine recombinant
aBL 206538
ziv-aflibercept
BL 125418
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Trurapi (insulin aspart) (Sanofi) (February-2021)
Biosimilars Approved In The E.U.
Admelog® (insulin lispro recombinant) (Sanofi) (July-2017)Insulin Aspart Sanofi (insulin aspart) (Sanofi) (July-2020)
Biosimilars Approved In Australia
Truvelog (insulin aspart) (Sanofi) (October-2020)
Inter Partes Review Proceedings
DUPIXENTIPR2017-01129IPR2017-01879IPR2017-01884GENENTECH CABILLYIPR2015-01624IPR2016-00383IPR2016-00460LANTUS / LANTUS SOLOSTARIPR2017-01526IPR2017-01528IPR2018-01670IPR2018-01675IPR2018-01676IPR2018-01677IPR2018-01678IPR2018-01679IPR2018-01680IPR2018-01682IPR2018-01684IPR2018-01696IPR2019-00122IPR2019-00977IPR2019-00978IPR2019-00979IPR2019-00980IPR2019-00981IPR2019-00982IPR2019-00987IPR2019-01022IPR2019-01023IPR2019-01657IPR2019-01658ZOLGENSMAIPR2023-00608IPR2023-00609IPR2023-01044IPR2023-01045LANTUS / LANTUS SOLOSTAR / SEMGLEEIPR2017-01526IPR2017-01528IPR2018-01670IPR2018-01675IPR2018-01676IPR2018-01677IPR2018-01678IPR2018-01679IPR2018-01680IPR2018-01682IPR2018-01684IPR2018-01696IPR2019-00122IPR2019-01657IPR2019-01658
U.S. Patent Litigations
DUPIXENT1:17-cv-10465 (D. Mass.)2:17-cv-02613 (C.D. Cal.)ELITEK2:15-cv-01143 (W.D. Wash.)ZALTRAP7:11-cv-09463 (S.D.N.Y.)ACTIVASE / CATHFLO ACTIVASE / AVASTIN / HERCEPTIN / PULMOZYME / RITUXAN / TNKASE / XOLAIR3:08-cv-04909 (N.D. Cal.)3:09-cv-04919 (N.D. Cal.)LANTUS / LANTUS SOLOSTAR / BASAGLAR1:14-cv-00113 (D. Del.)1:14-cv-00884 (D. Del.) LANTUS / LANTUS SOLOSTAR / LUSDUNA NEXVUE1:16-cv-00812 (D. Del.)2:17-cv-05914 (D.N.J.)LANTUS / LANTUS SOLOSTAR / SEMGLEE2:17-cv-09105 (D.N.J.)PRALUENT / GENENTECH CABILLY2:15-cv-05685 (C.D. Cal.)PRALUENT / REPATHA1:14-cv-01317 (D. Del.)1:14-cv-01349 (D. Del.)1:14-cv-01393 (D. Del.)1:14-cv-01414 (D. Del.)