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Samsung Epis Holdings

OUR PRODUCTS

Our Products

As a world-leader in biosimilars, we have one of the most
expansive and rapidly growing portfolios in the industry.

Samsung Bioepis has an extensive portfolio and pipeline of biosimilar medicines.

sb4 아이콘SB4

Etanercept Biosimilar

SB4 nations
Approved by EC (Europe)
in Jan 2016 Approved by MFDS (KR)
in Sep 2015 Approved by HC (Canada)
in Aug 2016 Approved by TGA (Australia)
in Jul 2016 Approved by MoH (Israel)
in Jan 2019 Approved by ANVISA (Brazil)
in Dec 2017 Approved by Swissmedic
in Sep 2018 Approved by Medsafe
(New Zealand) in Feb 2019 Approved by FDA (US)
in Apr 2019 Approved by TFDA (Taiwan)
in Sep 2021 Approved by MOPH (Qatar)
in Jul 2023 Approved by MHRA (UK)
in Jan 2021 Approved by MOHAP (UAE)
in Apr 2023
SB4 제공
Product Information Reference Biologic
SB4 Product Information
EC (Europe) Learn More
FDA (US) Learn More
TGA (AU) Learn More
MFDS (KR) Learn More
ENBREL®
  • BENEPALI™ is a trademark of Biogen.
  • BRENZYS™ is a trademark of Organon & Co.
  • ETOLOCE™ and ETICOVO™ is a trademark of Samsung Bioepis.
  • ENBREL® is a registered trademark of Wyeth.

sb2 아이콘SB2

Infliximab Biosimilar

SB2 nations
Approved by EC (Europe)
in May 2016 Approved by FDA (US)
in Apr 2017 Approved by MFDS (KR)
in Sep 2015 Approved by HC (Canada)
in Dec 2017 Approved by TGA (Australia)
in Nov 2016 Approved by ANVISA (Brazil)
in Jul 2018 Approved by Medsafe
(New Zealand) in Mar 2023 Approved by MOHAP (UAE)
in Nov 2023 Approved by SFDA
(Saudi Arabia) in Dec 2023 Approved by KDFC
(Kuwait) in Jan 2024 Approved by MHRA
(UK) in Jan 2021 Approved by TFDA
(Taiwan) in Jan 2023 Approved by MOPH
(Qatar) in Mar 2023
SB2 제공
Product Information Reference Biologic
SB2 Product Information
EC (Europe) Learn More
FDA (US) Learn More
TGA (AU) Learn More
MFDS (KR) Learn More
REMICADE®
  • FLIXABI™ is a trademark of Biogen.
  • RENFLEXIS™ is a trademark of Organon & Co.
  • REMALOCE™ is a trademark of Samsung Bioepis.
  • REMICADE® is a registered trademark of Janssen.

sb5 아이콘SB5

Adalimumab Biosimilar

SB5 nations
Approved by EC (Europe)
in Aug 2017 Approved by HC (Canada)
in May 2018 Approved by MFDS (KR)
in Sep 2017 Approved by TGA (Australia)
in Jan 2018 Approved by FDA (US)
in Jul 2019 Approved by Swissmedic
in Apr 2020 Approved by TFDA (Taiwan)
in Nov 2021 Approved by SFDA
(Saudi Arabia) in Aug 2021 Approved by MoH (Israel)
in Feb 2021 Approved by ANVISA (Brazil)
in May 2022 Approved by MHRA (UK)
in Jan 2021 Approved by MOPH (Qatar)
in Sep 2023
SB5 제공
Product Information Reference Biologic
SB4 Product Information
EC (Europe) Learn More
FDA (US) Learn More
MFDS (KR) Learn More
HUMIRA®
  • IMRALDI™ is a trademark of Biogen.
  • HADLIMA™ is a trademark of Organon & Co.
  • ADALLOCE™ is a trademark of Samsung Bioepis.
  • HUMIRA® is a registered trademark of AbbVie.

sb3 아이콘SB3

Trastuzumab Biosimilar

SB3 nations
Approved by EC (Europe)
in Nov 2017 Approved by MFDS (KR)
in Nov 2017 Approved by FDA (US)
in Jan 2019 Approved by TGA (Australia)
in Jan 2019 Approved by ANVISA (Brazil)
in May 2019 Approved by TFDA (Taiwan)
in Jul 2021 Approved by HC(Canada)
in Feb 2022 Approved by Medsafe (New Zealand) in Jan 2023 Approved by MOHAP
(UAE) in Nov 2023 Approved by MOPH
(Qatar) in Mar 2023 Approved by MHRA
(UK) in Jan 2021 Approved by Swissmedic
in Dec 2021 Approved by SFDA
(Saudi arabia) in Oct 2023
SB3 제공
Product Information Reference Biologic
SB3 Product Information
EC (Europe) Learn More
FDA (US) Learn More
TGA (AU) Learn More
MFDS (KR) Learn More
HERCEPTIN®
  • ONTRUZANT™ is a trademark of Organon & Co.
  • SAMFENET™ is a trademark of Samsung Bioepis.
  • HERCEPTIN® is a registered trademark of Genentech.

sb8 아이콘SB8

Bevacizumab Biosimilar

SB8 nations
Approved by EC (Europe)
in Aug 2020 Approved by MFDS (KR)
in Mar 2021 Approved by HC (Canada)
in Nov 2021 Approved by TFDA (Taiwan)
in Mar 2022 Approved by TGA (Australia)
in Jan 2024 Approved by MHRA (UK)
in Jan 2021 Approved by ANVISA (Brazil)
in Mar 2024
SB8 제공
Product Information Reference Biologic
SB8 Product Information
EC (Europe) Learn More
MFDS (KR) Learn More
TGA (AU) Learn More
AVASTIN®
  • AYBINTIO™ is a trademark of Organon & Co.
  • ONBEVZI™ is a trademark of Samsung Bioepis.
  • AVASTIN® is a registered trademark of Genentech.

sb11 아이콘SB11

Ranibizumab Biosimilar

SB11 nations
Approved by FDA (US)
in Sep 2021 Approved by HC (Canada)
in Feb 2022 Approved by EC (Europe)
in Aug 2021 Approved by MFDS (KR)
in May 2022 Approved by Swissmedic
in Jul 2022 Approved by TGA (Australia)
in Aug 2022 Approved by Medsafe
(New Zealand) in Mar 2023 Approved by MHRA
(UK) in Aug 2021 Approved by ANVISA
(Brazil) in Oct 2023 Approved by TFDA
(Taiwan) in Nov 2023 Approved by TFDA
(Taiwan) in Nov 2023 Approved by MoH
(Ukraine) in Jul 2024
SB11 제공
Product Information Reference Biologic
SB11 Product Information
EC (Europe) Learn More
FDA (US) Learn More
Interchangeability
(FDA Approval Letter)*
TGA (AU) Learn More
MFDS (KR) Learn More
LUCENTIS®
  • BYOOVIZ™ is a trademark of Biogen.
    *In the United States, BYOOVIZ™ (ranibizumab-nuna) is interchangeable to LUCENTIS® (ranibizumab injection) for the approved indications.
  • AMELIVU™ is a trademark of Samsung Bioepis.
  • LUCENTIS® is a registered trademark of Genentech.

sb12 아이콘SB12

Eculizumab Biosimilar

SB12 nations
Approved by EC (Europe) in
May 2023 Approved by MFDS (KR) in
Jan 2024 Approved by MHRA (UK) in
Oct 2023 Approved by FDA (US)
in Jul 2024 Approved by ANVISA (Brazil)
in Dec 2024
SB12 제공
Product Information Reference Biologic
SB12 Product Information
EC (Europe) Learn More
FDA (US) Learn More
MFDS (KR) Learn More
SOLIRIS®
  • EPYSQLI™ is a trademark of Samsung Bioepis.
  • SOLIRIS® is a registered trademark of Alexion.

sb15 아이콘SB15

Aflibercept Biosimilar

SB12 nations
Approved by MFDS (KR)
in Feb 2024 Approved by FDA (US)
in May 2024 Approved by MHLW (JP)
in Jun 2024 Approved by EC (Europe)
in Nov 2024
SB15 제공
Product Information Reference Biologic
SB15 Product Information
FDA (US) Learn More
EC (Europe) Learn More
MFDS (KR) Learn More
EYLEA®
  • While SB15 is approved in the EU (and the UK), it will not be launched until after expiry of relevant SPCs protecting the Reference Biologic Eylea. Launch dates for ex-EU or ex-UK may vary depending on various factors, including expiry of relevant patent protection.
  • OPUVIZ™ is a trademark of Biogen.
  • AFILIVU™ is a trademark of Samsung Bioepis.
  • EYLEA® is a registered trademark of Regeneron.

sb17 아이콘SB17

Ustekinumab Biosimilar

SB17 nations
Approved by MFDS (KR)
in Apr 2024 Approved by EC (Europe)
in Apr 2024 Approved by MHRA (UK)
in May 2024 Approved by FDA (US)
in Jun 2024 Approved by HC (Canada)
in Aug 2024 Approved by TGA (Australia)
in Sep 2024
SB17 제공
Product Information Reference Biologic
SB17 Product Infomation
EC (Europe) Learn More
FDA (US) Learn More
MFDS (KR) Learn More
STELARA®
  • PYZCHIVA™ is a trademark of Samsung Bioepis.
  • EPYZTEK™ is a trademark of Samsung Bioepis.
  • STELARA® is a registered trademark of Janssen.
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