European Commission approves Imraldi, a biosimilar referencing Humira (adalimumab) to treat the originator drug indications- Biogen.
Samsung Bioepis Co., Ltd. announced the European Commission’s (EC) approval of Imraldi, a biosimilar referencing Humira (adalimumab), 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.
With the EC’s marketing authorization of Imraldi , Samsung Bioepis becomes the industry’s first to European approvals for biosimilars referencing all three anti-TNF-? blockbusters. Benepali (etanercept) and Flixabi (infliximab) received EC marketing authorization in January 2016 and May 2016, respectively.
Comment: Biogen have marketing rights to Imraldi in the EU.
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