Most Popular
-
1
Blinken calls on China to press N. Korea to end its 'dangerous' behavior
-
2
New celebrity-endorsed therapy for face contouring requires only a pair of rubber bands
-
3
Tensions heighten ahead of first president-opposition chief meeting
-
4
[Weekender] How DDP emerged as an icon of Seoul
![[Weekender] How DDP emerged as an icon of Seoul](//res.heraldm.com/phpwas/restmb_idxmake.php?idx=644&simg=/content/image/2024/04/25/20240425050915_0.jpg&u=)
-
5
Doctor group's incoming head renews call for govt. to scrap medical school quota hike for dialogue
![[Weekender] How DDP emerged as an icon of Seoul](http://res.heraldm.com/phpwas/restmb_idxmake.php?idx=644&simg=/content/image/2024/04/25/20240425050915_0.jpg&u=)
-
6
Seoul to provide housing subsidy to married couples with newborns
-
7
Rapper jailed after public street fight with another rapper
-
8
[Music in drama] An ode to childhood trauma
![[Music in drama] An ode to childhood trauma](//res.heraldm.com/phpwas/restmb_idxmake.php?idx=644&simg=/content/image/2024/04/25/20240425050929_0.jpg&u=)
-
9
'The Roundup: Punishment' becomes fastest 2024 film to top 2 mln admissions
-
10
NewJeans pops out ‘Bubble Gum’ video amid troubles at agency
![[Music in drama] An ode to childhood trauma](http://res.heraldm.com/phpwas/restmb_idxmake.php?idx=644&simg=/content/image/2024/04/25/20240425050929_0.jpg&u=)
Samsung Bioepis’ Remicade biosimilar approved in Europe
By Sohn Ji-youngPublished : May 30, 2016 - 16:04
Samsung Bioepis said Monday that Flixabi, its biosimilar drug referencing Johnson & Johnson’s blockbuster rheumatoid arthritis treatment Remicade, has been approved by the European Medicines Agency.
The EMA has approved Flixabi for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis, the company said.
It is the second Remicade (infliximab) biosimilar to be approved by the European drug agency after Korean biopharma company Celltrion’s Inflectra, which was approved in June 2013.
With the approval, Samsung’s Flixbi is geared to directly compete with not only J&J’s Remicade but also Celltrion’s Inflectra, which began sales in Europe in 2014.
“With this approval, we are taking another important step in broadening affordable, high-quality biologic treatment options across Europe,” Samsung Bioepis president and CEO Ko Han-sung said in a statement.
Biogen, Samsung Bioepis’ European sales and marketing partner, will commercialize Flixabi in the European Union member states as well as in Norway, Iceland and Liechtenstein, the firm said.
Flixabi is Samsung Bioepis’ second biosimilar to win EMA approval. Benepali, its biosimilar drug referencing Enbrel (etanercept), was approved by the European drug regulator earlier in January.
By Sohn Ji-young (jys@heraldcorp.com)
The EMA has approved Flixabi for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis, the company said.
It is the second Remicade (infliximab) biosimilar to be approved by the European drug agency after Korean biopharma company Celltrion’s Inflectra, which was approved in June 2013.
With the approval, Samsung’s Flixbi is geared to directly compete with not only J&J’s Remicade but also Celltrion’s Inflectra, which began sales in Europe in 2014.
“With this approval, we are taking another important step in broadening affordable, high-quality biologic treatment options across Europe,” Samsung Bioepis president and CEO Ko Han-sung said in a statement.
Biogen, Samsung Bioepis’ European sales and marketing partner, will commercialize Flixabi in the European Union member states as well as in Norway, Iceland and Liechtenstein, the firm said.
Flixabi is Samsung Bioepis’ second biosimilar to win EMA approval. Benepali, its biosimilar drug referencing Enbrel (etanercept), was approved by the European drug regulator earlier in January.
By Sohn Ji-young (jys@heraldcorp.com)
![[Herald Interview] Mistakes turn into blessings in street performance, director says](http://res.heraldm.com/phpwas/restmb_idxmake.php?idx=652&simg=/content/image/2024/04/28/20240428050150_0.jpg&u=20240428174656)
