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Samsung Bioepis’ Remicade biosimilar approved in Europe

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.

Samsung Bioepis' headquarters in Songdo, Incheon (Samsung Bioepis)
Samsung Bioepis' headquarters in Songdo, Incheon (Samsung Bioepis)

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 (
Korea Herald Youtube