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EMA recommends approval of Humira biosimilar Imraldi

EMA recommends approval of Humira biosimilar Imraldi
June 23, 2017

The European Medicines Agency has recommended the approval of the Imraldi, making it the third anti-TNF biosimilar candidate to receive a positive opinion from the Committee for Medicinal Products for Human Use, the manufacturer announced.

Imraldi (SB5, Samsung Bioepis) is a biosimilar candidate referencing Humira (adalimumab, AbbVie), indicated for rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hydradentis suppurativa, Crohn’s disease in adults and children, ulcerative colitis and uveitis.

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