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Biosimilar to Humira approved in Europe
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Samsung Bioepis Co. Ltd. announced the European Commission has approved Imraldi, a biosimilar to Humira, 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, according to a company press release.
“We are proud to become the industry’s first to obtain European approval for a third [tumor necrosis factor] TNF inhibitor,” Christopher Hansung Ko, president and chief executive officer of Samsung, said in the release. “This is a testament to our agile biologics development platform, which has allowed us to develop approved biosimilars in less time at lower cost.”
Samsung also has European Commission approval for biosimilars to etanercept and infliximab. Biogen will commercialize Imraldi.
“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 health care systems across Europe will benefit from biosimilars,” Ko said.
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