FDA Approved Biologics and Pending Applications
ranibizumab-nuna
aBL 761202
etanercept-ykro
aBL 761066
adalimumab-bwwd
aBL 761059
trastuzumab-dttb
aBL 761100
infliximab-abda
BL 761054
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)Flixabi (infliximab) (Samsung Bioepsis) (May-2016)Imraldi (adalimumab) (Samsung Bioepis) (August-2017)Onbevzi (bevacizumab) (Samsung Bioepis) (January-2021)Onbevzi (bevacizumab) (Samsung Bioepis) (January-2021)Onbevzi (bevacizumab) (Samsung Bioepis) (January-2021)Onbevzi (bevacizumab) (Samsung Bioepis) (January-2021)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)Amelivu (ranibizumab) (Samsung Bioepis) (May-2022)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)