SAMSUNG BIOEPIS

FDA Approved Biologics and Pending Applications

Byooviz

ranibizumab-nuna
aBL 761202

Epysqli

eculizumab-aagh
aBL 761340

Eticovo®

etanercept-ykro
aBL 761066

Hadlima

adalimumab-bwwd
aBL 761059

Ontruzant®

trastuzumab-dttb
aBL 761100

Opuviz

aflibercept-yszy
aBL 761350

Pyzchiva®

ustekinumab-ttwe
aBL 761373 / aBL 761425

Renflexis®

infliximab-abda
BL 761054

SB16

denosumab
SB16 Approval Pending

SB8

bevacizumab
SB8 Approval Pending

Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Aybintio (bevacizumab) (Samsung Bioepis) (November-2021)Brenzys (etanercept) (Samsung Bioepis / Merck Canada) (August-2016)Byooviz (ranibizumab) (Samsung Bioepis / Biogen) (March-2022)Hadlima (Samsung Bioepis) (May-2018, high-concentration January-2023)Ontruzant® (trastuzumab) (Samsung Bioepis) (February-2022)Renflexis (infliximab) (Samsung Bioepis) (March-2018)

Biosimilars Approved In The E.U.

Aybintio (bevacizumab) (Samsung Bioepis) (August-2020) Benepali (etanercept) (Samsung Bioepis / Biogen) (January-2016)Byooviz (ranibizumab) (Samsung Bioepis / Biogen) (August-2021)Eksunbi (ustekinumab) (Samsung Bioepis) (September-2024)Epysqli (eculizumab) (Samsung Bioepis) (May-2023)Flixabi (infliximab) (Samsung Bioepsis) (May-2016)Imraldi (adalimumab) (Samsung Bioepis) (August-2017)Onbevzi (bevacizumab) (Samsung Bioepis) (January-2021)Ontruzant® (trastuzumab) (Samsung Bioepis) (November-2017)Opuviz (aflibercept) (Samsung Bioepis / Biogen) (November-2024)Pyzchiva® (ustekinumab) (Sandoz / Samsung Bioepis) (April-2024)

Biosimilars Approved In Australia

Brenzys (etanercept) (Samsung Bioepis) (July-2016)Byooviz (ranibizumab) (Samsung Bioepis) (August-2022)Hadlima (adalimumab) (Samsung Bioepis) (January-2018)Onbevzi® (bevacizumab) (Samsung Bioepis) (January-2024)Ontruzant® (trastuzumab) (Samsung Bioepis) (January-2019) Renflexis (infliximab) (Samsung Bioepis / Merck) (November-2016)

Biosimilars Approved In South Korea

Adalloce (adalimumab) (Samsung Bioepis) (September-2017, high-concentration January-2023)Afilivu (aflibercept) (Samsung Bioepis / Samil) (February-2024)Amelivu (ranibizumab) (Samsung Bioepis) (May-2022)Epysqli (eculizumab) (Samsung Bioepis) (January-2024)Epyztek (ustekinumab) (Samsung Bioepis) (April-2024)Etoloce (etanercept) (Samsung Bioepis) (September-2015)Onbevzi® (bevacizumab) (Boryung Pharmaceutical / Samsung Bioepis) (September-2021)Remaloce (infliximab) (Samsung Bioepis / Merck) (December-2015)Samfenet (trastuzumab) (Samsung Bioepis) (November-2017)

Inter Partes Review Proceedings

EYLEA / OPUVIZIPR2023-00442
IPR2023-00566
IPR2023-00739
IPR2023-00884
IPR2023-01312
IPR2025-00176
HERCEPTIN / ONTRUZANTIPR2017-01958
IPR2017-01959
IPR2017-01960
IPR2017-02139
IPR2017-02140
IPR2018-00192
SOLIRIS / EPYSQLIIPR2023-00933
IPR2023-00998
IPR2023-00999
IPR2023-01069
IPR2023-01070
STELARA / PYZCHIVAIPR2023-01103

U.S. Patent Litigations

AVASTIN / SB81:20-cv-00859 (D. Del.)
ENBREL / ETICOVO2:19-cv-11755 (D.N.J.)
EYLEA / OPUVIZ1:23-cv-00094 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)
1:23-cv-00106 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)
HERCEPTIN / ONTRUZANT / GENENTECH CABILLY1:18-cv-01363 (D. Del.)
PROLIA / XGEVA / SB161:24-cv-08417 (D.N.J.)
REMICADE / RENFLEXIS2:17-cv-03524 (D.N.J.)
SOLIRIS / EPYSQLI1:24-cv-00005 (D. Del.)