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Biz News Korea(Eng)
Samsung Bioepis gets European nod to sell RA biosimiar Flixabi
- Collected
- 2016.05.31
- Distributed
- 2016.06.01
- Source
- Go Direct
Flixabi was approved in Korea late last year under the brand name of Renflexis, indicated for the treatment of RA, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis and psoriasis. According to the company on Monday, the drug can be available gradually in 28 EU members and three of the European Economic Area (EEA) countries.
Flixabi’s reference drug is Remicade, a blockbuster autoimmune treatment of Johnson & Johnson, whose sales hit around 9 trillion won (about $7.56 billion) worldwide in 2014. The approval comes after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the drug for marketing approval in April.
“Samsung Bioepis can now sell two biosimilar drugs, Benepali and Flixabi, in Europe. Flixabi and Benepali are different from each other in routes of administration and dose schedule, providing more treatment options to doctors,” said Ko Han-sung, president of Samsung Bioepis.
The company also filed an application with the U.S. Food and Drug Administration (FDA) seeking approval for the drug last Tuesday.
By Lee Dong-in
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