Samsung Bioepis krijgt met Imraldi® (adalimumab) als eerste Europese goedkeuring voor derde Anti-TNF-α-biosimilar
INCHEON, Korea–(BUSINESS WIRE)– Samsung Bioepis Co., Ltd. heeft vandaag bekendgemaakt dat de Europese Commissie de biosimilar Imraldi®, heeft goedgekeurd voor de behandeling van reumatoïde artritis, juveniele idiopathische artritis, axiale spondyloartritis, artritis psoriatica, psoriasis, pediatrische psoriasis en plaque, hidradenitis suppurativa bij volwassenen en adolescenten, de ziekte van Crohn, pediatrische ziekte van Crohn, colitis ulcerosa en uveïtis. Imraldi® is een biosimilar van Humira ® 1 (adalimumab).
Als gevolg van de vergunning van de EC voor Imraldi® is Samsung Bioepis het eerste bedrijf in de sector dat Europese toestemming heeft gekregen voor alle drie de anti-TNF-α-blockbusters. Benepali ® (etanercept) en Flixabi ® (infliximab) zijn in januari en mei 2016 al goedgekeurd door de EC.
Samsung Bioepis First to Obtain European Commission Approval for a Third Anti-TNF-α Biosimilar with Imraldi® (adalimumab) |
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INCHEON, Korea–(BUSINESS WIRE)– Samsung Bioepis Co., Ltd. today 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. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170824006317/en/  Christopher Hansung Ko, President & CEO of Samsung Bioepis. (Photo: Business Wire)
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. “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. 1 Humira ® is a registered trademark of AbbVie Inc. View source version on businesswire.com: http://www.businesswire.com/news/home/20170824006317/en/ Contacts Samsung Bioepis Co., Ltd. |
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