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Biz News Korea(Eng)
Samsung Bioepis gets EC approval for its third anti-TNF-α biosimilar with Imraldi
- Collected
- 2017.08.25
- Distributed
- 2017.08.29
- Source
- Go Direct
Humira is the world’s best-selling biologic drug for the treatment of autoimmune diseases such as rheumatoid arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis and psoriasis. Annual sales of Humira reached about 18 trillion won ($16 billion) last year, which represented 60 percent of Humira`s manufacturer AbbVie.
The EC approval of Imraldi follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in June 2017.
With the EC’s marketing authorization of Imraldi, Samsung Bioepis becomes the industry’s first to receive European approvals for biosimilars referencing all three anti-TNF-α blockbusters, which are Humira (adalimumab), Janssen’s Remicade (infliximab) and Amgen’s Enbrel (etarnercept). Worldwide sales of these three biologics amounted to $32.8 billion last year.
Samsung Bioepis has already marketed Benepali (etanercept) referencing Enbrel and Flixabi (infliximab) referencing Remicade across Europe after receiving EC marketing authorization in January 2016 and May 2016, respectively.
When to market Imraldi will be determined in consultation with Biogen, the exclusive distributor for Samsung Bioepis in Europe, considering the patent expiration of Humira. Samsung Bioepis is a joint-venture between Samsung Biologics and Biogen.
At 2:00 p.m., shares of Biologics were up 0.9 percent at 282,000 won.
By Shin Chan-ok
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