FDA Approved Biologics and Pending Applications
bevacizumab
BAT1706 Approval Pending
trastuzumab
EG12014 Approval Pending
etanercept-szzs
aBL 761042
denosumab
GP2411 Approval Pending
adalimumab-adaz
aBL 761071
somatropin
aBL 021426
rituximab
Rixathon® Approval Pending
ustekinumab
SB17 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)Omnitrope® (somatropin) (Sandoz) (April-2009)Riximyo® (rituximab) (Sandoz) (April-2020) Ziextenzo® (pegfilgrastim) (Sandoz) (April-2020)
Biosimilars Approved In The E.U.
Binocrit (epoetin alfa) (Sandoz) (August-2007)Erelzi (etanercept) (Sandoz) (June-2017)Herwenda® (trastuzumab) (EirGenix / Sandoz) (November-2023)Hyrimoz® (adalimumab) (Sandoz) (July-2018 low-concentration, April-2023 high-concentration)Omnitrope® (somatropin) (Sandoz) (April-2006)Rixathon® (rituximab) (Sandoz) (June-2017) Riximyo® (rituximab) (Sandoz) (June-2017)Riximyo® (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)
Biosimilars Approved In Japan
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.) 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 / GP24111:23-cv-02406 (D.N.J.)RITUXAN / RIXATHON / GENENTECH CABILLY1:17-cv-13507 (D.N.J.)TYSABRI / TYRUKO1:22-cv-01190 (D. Del.)
