ABOUT US
Who We Are
Samsung Bioepis reimagines and redefines the way medicines are made.
We make quality-assured biologic medicines more accessible, more quickly
Samsung Bioepis is a biopharmaceutical company dedicated to unlocking the
potential of biosimilar medicines and transforming the way
biologic
therapies are brought to patients. Our mission is reflected in our name,
bio-epis; literally meaning life (“bio”) and science (“episteme”) in
Greek.
We want to enhance the lives of patients through our pioneering
and innovative use of science and technology.
Our achievements
Since our establishment in 2012, we have developed one of the most expansive and rapidly growing biosimilars portfolios in the industry. We received European approval and FDA approval for etanercept biosimilar, infliximab biosimilar, adalimumab biosimilar, ustekinumab biosimilar, trastuzumab biosimilar, ranibizumab biosimilar, aflibercept biosimilar, eculizumab biosimilar, and denosumab biosimilar. Also, we received European approval for bevacizumab biosimilar.
Our partners
We work hand in hand with other carefully chosen partners to commercialize our products around the world and ensure supply and access for the people who need them. Our partners include Biogen, Organon, Sandoz, Teva, and Harrow. We also have established our own direct commercialization network for several countries.
Our future
As long as patients face barriers to accessing the medicines they need, we will continue to strive for constant innovation. We are expanding into new areas of unmet need, we are also harnessing our smart development process for biosimilars to develop the next generation of novel biologics Including ADC(Antibody Drug Conjugates). Our work has only just begun.
Since our launch in 2012, we have developed the industry’s most rapidly advancing biosimilar medicines portfolio and have become a leader in biosimilars.
- Samsung Bioepis is
established - Samsung Bioepis opens
R&D Center
- Partnership with Merck&Co.i)
- Partnership with Biogen
- 2 biosimilars (infliximab and
etanercept) approved by
MFDS (Korea)
- 2 biosimilars (infliximab and
etanercept) approved by EC
(Europe)
- 1 biosimilar (infliximab)
approved by FDA (US) - 2 biosimilars (adalimumab and
trastuzumab) approved by EC
(Europe) - 2 biosimilars (adalimumab and
trastuzumab) approved by
MFDS (Korea)
- 3 biosimilars (trastuzumab,
etanercept and adalimumab)
approved by FDA (US)
- 1 biosimilar (bevacizumab)
approved by EC (Europe)
- Opening of the New
Headquarters - 1 biosimilar (bevacizumab)
approved by MFDS (Korea) - 1 biosimilar (ranibizumab)
approved by EC (Europe) - 1 biosimilar (ranibizumab)
approved by FDA (US)
- 1 biosimilar (ranibizumab)
approved by MFDS (Korea) -
Citrate-free, high-concentration adalimumab biosimilar approved by the FDA (US)
- 1 biosimilar (eculizumab)
approved by EC (Europe) and UK (MHRA) - 1 biosimilar (ranibizumab) approved as interchangeable by FDA (US)
- Partnership with Sandoz
- Partnership with IntoCell for ADC development
- 1 biosimilar (eculizumab) approved by MFDS (Korea) and FDA (US)
- 1 biosimilar (aflibercept) approved by MFDS (Korea), FDA (US) and EC (Europe)
- 1 biosimilar (Ustekinumab) approved by EC (Europe), UK (MHRA), MFDS (Korea) and FDA (US)
- Partnership with Teva
- Partnership with Harrow
- 1 biosimilar (aflibercept) approved by UK (MHRA)
- 1 biosimilar (denosumab) approved by EC (Europe), UK (MHRA), FDA (US) and MFDS (Korea)
- Partnership with Phrontline Biopharma for ADC development
- Spin off of Samsung Bioepis from Samsung Biologics and establishment of Samsung Epis Holdings
- IND clearance from the FDA (US) for SBE303 (Nectin-4 targeted ADC candidate)
- Partnership with G2GBIO for novel assets
i) We are in partnership with Organon, which spinoff from Merck in June 2021.
At Samsung Bioepis we believe our fresh approach to harnessing
science and technology is the key unlocking the health care of the future.
We will put our passion for health to work and strive for constant innovation.
"We are relentless in our mission to speed up and enhance the development of
quality-assured biosimilars because people shouldn't wait for the life-changing
medicines they need."
