FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EC Approves Humira Biosimilar Imraldi for Arthritis and More

Aug. 31, 2017
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The European Commission granted a marketing authorization to the arthritis drug Imraldi, a Samsung Bioepis biosimilar to AbbVie’s Humira (adalimumab), Samsung Bioepis said.

The medicine is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis.

Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen.

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