FDA Approved Biologics and Pending Applications
bevacizumab-tnjn
aBL 761198
ranibizumab-eqrn
aBL 761165
trastuzumab
EG12014 Approval Pending
aflibercept-abzv
aBL 761382
etanercept-szzs
aBL 761042
adalimumab-adaz
aBL 761071
denosumab-bbdz
aBL 761362
somatropin
aBL 021426
ustekinumab-ttwe
aBL 761373 / aBL 761425
rituximab
Rixathon® Approval Pending
natalizumab-sztn
aBL 761322
filgrastim-sndz
aBL 125553
pegfilgrastim-bmez
aBL 761045
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Erelzi (etanercept) (Sandoz) (April-2017)Hyrimoz® (adalimumab) (Sandoz Canada) (November-2020)Jubbonti® / Wyost® (denosumab) (Sandoz) (February-2024)Omnitrope® (somatropin) (Sandoz) (April-2009)Riximyo® (rituximab) (Sandoz) (April-2020) Ziextenzo® (pegfilgrastim) (Sandoz) (April-2020)
Biosimilars Approved In The E.U.
Afqlir® (aflibercept) (Sandoz) (November-2024)Binocrit (epoetin alfa) (Sandoz) (August-2007)Erelzi (etanercept) (Sandoz) (June-2017)Herwenda® (trastuzumab) (EirGenix / Sandoz) (November-2023)Hulio® (adalimumab) (Mylan / Fujifilm Kyowa Kirin Biologics) (September-2018)Hyrimoz® (adalimumab) (Sandoz) (July-2018 low-concentration, April-2023 high-concentration)Jubbonti® / Wyost® (denosumab) (Sandoz) (May-2024)Omnitrope® (somatropin) (Sandoz) (April-2006)Pyzchiva® (ustekinumab) (Sandoz / Samsung Bioepis) (April-2024)Rixathon® (rituximab) (Sandoz) (June-2017) Riximyo® (rituximab) (Sandoz) (June-2017)Tyruko® (natalizumab) (Sandoz / Polpharma) (September-2023)Zarzio (filgrastim) (Sandoz) (February-2009)Zessly (infliximab) (Sandoz) (May-2018Ziextenzo® (pegfilgrastim) (Sandoz) (November-2018)
Biosimilars Approved In Australia
Erelzi (etanercept) (Sandoz) (November-2017)Hyrimoz® (adalimumab) (Sandoz) (May-2019)Novicrit (epoetin lambda) (Sandoz) (January-2010)Omnitrope® (somatropin) (Sandoz) (September-2010)Riximyo® (rituximab) (Sandoz) (November-2017) Zarzio (filgrastim) (Sandoz) (May-2013)Ziextenzo® (pegfilgrastim) (Sandoz) (September-2019)
Biosimilars Approved In Japan
Adalimumab BS (adalimumab) (Fujifilm Kyowa Kirin Biologics / Viatris / Sandoz) (June-2020)Filgrastim BS (filgrastim) (Sandoz) (March-2014)Somatropin BS (somatropin) (Sandoz) (June-2009)
Biosimilars Approved In South Korea
Omnitrope® (somatropin) (Sandoz) (June-2009)
Inter Partes Review Proceedings
U.S. Patent Litigations
ENBREL / ERELZI2:16-cv-01118 (D.N.J.) 3:13-cv-02904 (N.D. Cal.) ENBREL / ETICOVO2:19-cv-11755 (D.N.J.) EYLEA / ENZEEVU1:24-cv-00085 (N.D.W. Va.) (transferred from 2:24-cv-08760 (D.N.J.)) / MDL 1:24-md-03103 (N.D.W. Va.)HUMIRA / HYRIMOZ3:18-cv-12668 (D.N.J.)NEULASTA / ZIEXTENZO2:16-cv-01276 (D.N.J.)3:16-cv-02581 (N.D. Cal.)3:19-cv-00977 (N.D. Cal.) NEUPOGEN / ZARXIO3:14-cv-04741 (N.D. Cal.) 3:19-cv-00977 (N.D. Cal.) NEUPOGEN / ZARXIO / NEULASTA / ZIEXTENZO3:19-cv-00977 (N.D. Cal.) PROLIA / XGEVA / JUBBONTI / WYOST1:23-cv-02406 (D.N.J.)RITUXAN / RIXATHON / GENENTECH CABILLY1:17-cv-13507 (D.N.J.)TYSABRI / TYRUKO1:22-cv-01190 (D. Del.)
