SAMSUNG BIOEPIS

SAMSUNG BIOEPIS

approved_indications FDA Approved Biologics and Pending Applications

Byooviz

ranibizumab-nuna
aBL 761202

Eticovo®

etanercept-ykro
aBL 761066

Hadlima

adalimumab-bwwd
aBL 761059

Ontruzant®

trastuzumab-dttb
aBL 761100

Renflexis®

infliximab-abda
BL 761054

SB12

eculizumab
SB12 Approval Pending

SB15

aflibercept
SB15 Approval Pending

SB17

ustekinumab
SB17 Approval Pending

SB8

bevacizumab
SB8 Approval Pending

approved_indications 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)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)

Biosimilars Approved In Australia

Brenzys (etanercept) (Samsung Bioepis) (July-2016)Hadlima (adalimumab) (Samsung Bioepis) (January-2018)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)Onbevzi® (bevacizumab) (Boryung Pharmaceutical / Samsung Bioepis) (September-2021)Renflexis (infliximab) (Samsung Bioepis / Merck) (December-2015)SB4 (Brenzys/Benepali) (etanercept) (Samsung Bioepis) (September-2015)Samfenet (trastuzumab) (Samsung Bioepis) (November-2017)

approved_indications Inter Partes Review Proceedings

EYLEA / SB15IPR2023-00442
IPR2023-00566
IPR2023-00739
IPR2023-00884
IPR2023-01312
HERCEPTIN / ONTRUZANTIPR2017-01958
IPR2017-01959
IPR2017-01960
IPR2017-02139
IPR2017-02140
IPR2018-00192
SOLIRIS / SB12IPR2023-00933
IPR2023-00998
IPR2023-00999
IPR2023-01069
IPR2023-01070
STELARA / SB17IPR2023-01103

approved_indications U.S. Patent Litigations

AVASTIN / SB81:20-cv-00859 (D. Del.)
ENBREL / ETICOVO2:19-cv-11755 (D.N.J.)
EYLEA / SB151:23-cv-00094 (N.D.W. Va.)
1:23-cv-00106 (N.D.W. Va.)
HERCEPTIN / ONTRUZANT / GENENTECH CABILLY1:18-cv-01363 (D. Del.)
REMICADE / RENFLEXIS2:17-cv-03524 (D.N.J.)
SOLIRIS / SB121:24-cv-00005 (D. Del.)

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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