Regulatory Affairs

Samsung Bioepis’ Humira biosimilar Imraldi approved in Europe

EBR Staff Writer Published 28 August 2017

Samsung Bioepis' Imraldi, the anti-TNF biosimilar of Humira (adalimumab), has been approved by the European Commission (EC) for all indications of the AbbVie monoclonal antibody.

The Humira biosimilar can now be used in Europe for treating rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, ulcerative colitis, uveitis, Crohn’s disease and pediatric Crohn’s disease.

Following its marketing authorization in Europe, Samsung Bioepis is the first company to secure European approvals for biosimilars referencing all three anti-TNF-α candidates.

Last year, Samsung Bioepis had got EC approvals for Benepali (etanercept) and Flixabi (infliximab).

Samsung Bioepis president & CEO Christopher Hansung Ko said: “This is a testament to our agile biologics development platform, which has allowed us to develop approved biosimilars in less time at lower cost.

“Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry's strongest biosimilar pipelines, so that more patients and healthcare systems across Europe will benefit from biosimilars.”

Imraldi will be available as a new option for all indications of Humira across 28 member states of the European Union (EU) along with the European Economic Area (EEA) member states of Norway, Liechtenstein and Iceland.

Its approval by the EC comes after the recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in June. The positive opinion adopted by CHMP was based on the results of a randomized and double-blind 52-week phase 3 study in 544 patients.

Biogen, the joint venture partner of Samsung BioLogics in Samsung Bioepis, will commercialize Imraldi in the EU and EEA countries.