Samsung Bioepis First to Obtain European Commission Approval for a Third Anti-TNF-α Biosimilar with Imraldi™ (adalimumab)
INCHEON, Korea – August 25, 2017 – Samsung Bioepis Co., Ltd. today announced the European Commission’s (EC) approval of Imraldi®, a biosimilar referencing Humira®i (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-α blockbusters. Benepali® (etanercept) and Flixabi® (infliximab) received EC marketing authorization in January 2016 and May 2016, respectively.
“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.”
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 EU 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.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that includes six first-wave candidates that cover the therapeutic areas of immunology, oncology and diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.
i Humira® is a registered trademark of AbbVie Inc.