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Mark Peters : August 25th 2017 - 12:12 CET

Samsung Bioepis receives European authorization


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SamsungSamsung Bioepis gets approval from European Commission : Samsung Bioepis announced the European Commission’s (EC) approval of Imraldi, a biosimilar referencing Humira 1 (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 receive European approvals for biosimilars referencing all three anti-TNF-α blockbusters. Benepali (etanercept) and Flixabi (infliximab) received EC marketing authorization in January 2016 and May 2016, respectively.
Samsung healthcare division

Samsung healthcare division
The EC approval of Imraldi applies to all 28 European Union (EU) member states as well as the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. Biogen will commercialize Imraldi in the European Union and EEA member states.

The EC approval of Imraldi follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in June 2017.

Samsung Bioepis

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

"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.", Christopher added.




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