EU regulator clears Samsung Bioepis' Imraldi as biosimilar version of AbbVie's Humira

Samsung Bioepis said that the European Commission authorised Imraldi as a biosimilar version of AbbVie's Humira (adalimumab) for the treatment of conditions including rheumatoid arthritis, psoriasis, Crohn's disease and ulcerative colitis. Amgen's Amgevita became the first biosimilar version of Humira to be approved in the EU, following its clearance in March.

Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen, noted that it is the first drugmaker to gain European approval for a third TNF inhibitor biosimilar, following last year's clearance of Benepali (etanercept) and Flixabi (infliximab). The company said that the indications for Imraldi also include juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, paediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa and uveitis.

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"We are proud to become the industry's first to obtain European approval for a third TNF inhibitor," commented Christopher Hansung Ko, CEO of Samsung Bioepis, adding "this is a testament to our agile biologics development platform, which has allowed us to develop approved biosimilars in less time at lower cost."

Biogen indicated that anti-TNF therapies cost European countries an estimated $9 billion per year from 2011 to 2014, while introducing biosimilar versions of the top three anti-TNF therapies in the region could save up to $11.4 billion between the patent expiry date of each reference product and 2020.

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