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Celltrion launches world’s first biosimilar monoclonal antibody Remsima™ in 12 new European markets

등록일 2015-02-25
Now available in 31 countries for the treatment of autoimmune diseases

25 February 2015, Incheon, Republic of Korea. Celltrion Healthcare has today announced the launch of Remsima™ (infliximab) in 12 European markets: Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain, Sweden and the UK.

Remsima™, developed by Celltrion, Inc., is the world’s first biosimilar monoclonal antibody (mAb) to be approved by the European Medicines Agency (EMA). It is indicated for the treatment of adult and pediatric Crohn’s disease (CD), adult and pediatric ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, and psoriatic arthritis.[1] Remsima™ is an anti-tumor necrosis factor (anti-TNF) mAb that is used for reducing inflammation and improving other symptoms of the diseases for which it is indicated.1

Dr Antonio López-SanRomán, a specialist in Gastroenterology at the University Hospital Ramón y Cajal, Spain said: “It is encouraging to know that patients across the whole of Europe with diseases like Crohn’s and ulcerative colitis now have an additional treatment option in Remsima™. It has already been used successfully around the world, and the availability of biosimilars such as Remsima™ could lead to cost savings to the healthcare system.”

While biologics have positively impacted patient treatment, the high cost of using such drugs places a considerable burden on healthcare systems and can affect patient access to treatment.[2] Biosimilars have the potential to offer cost savings for health services, particularly as they are often used to treat long-term conditions.[3] The use of biosimilars may help to increase patient access to treatment and allow patients to be treated earlier in their disease pathway.[4]

Celltrion Healthcare has announced data demonstrating the healthcare savings achievable by using Remsima™ to treat patients with CD in France, Italy and the UK.[5] The budget impact analysis, presented at the European Crohn’s and Colitis Organisation’s (ECCO) 10th annual congress in Barcelona, Spain, shows that total five-year savings across the three countries ranged from €76 million to €336 million.5 Biosimilars are projected to save health systems in Europe €11.8 billion to €33.4 billion between 2007 and 2020, with the biggest savings predicted in France, Germany and the UK.[6] Biosimilar mAbs are expected to deliver the greatest savings, ranging from €1.8 to €20.4 billion.6 

Dr Stanley Hong, President of Celltrion Healthcare, said: “Autoimmune diseases can have a devastating impact on people’s lives so we are proud that Remsima™ is available for patients across the European Union, offering them a more accessible treatment option to manage their disease.”

Clinical trials have demonstrated comparability of Remsima™ in quality, safety and efficacy to its reference medicinal product Remicade.[7],[8] Remsima™ received marketing authorization from the EMA on 10 September 2013 and is currently under review by the United States Food and Drug Administration.

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Notes to editors:

About Celltrion Healthcare

Celltrion Healthcare conducts worldwide marketing, sales, and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries, including both developed and emerging markets. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA’s cGMP and the EMA’s GMP standards. For more information please visit: http://www.celltrionhealthcare.com/

[1] European Medicines Agency. Remsima™. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002576/WC500150872.pdf. [Last accessed February 2015].
[2] World Health Organisation. Access to biotherapeutic products including similar biotherapeutic products and ensuring their quality, safety and efficacy. 2014. WHA67.21. Available at http://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_R21-en.pdf. [Last accessed February 2015].
[3] European Commission. What you need to know about biosimilar medicinal products. Available at http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf [Last accessed February 2015].
[4] Factors Supporting a Sustainable European Biosimilar Medicines Market. European Biosimilars Group September 2014. Available at www.egagenerics.com/images/Website/GfK_Final_Report-_Factors_Supporting_a_Sustainable_European_Biosimilar_Medicines_Market.pdf [Last accessed February 2015].
[5] Kim J. et al. 5 year budget impact analysis of CT-P13 (Infliximab) for the treatment of Crohn's disease in UK, Italy and France. ECCO 2015. Abstract no. A-1330.

[6] Saving Money in the European Healthcare Systems with Biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;1(3-4).120-6. http://gabi-journal.net/saving-money-in-the-european-healthcare-systems-with-biosimilars.html [Last accessed February 2015].

[7] Yoo D H, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72 (10), 1613-20. Available at: http://ard.bmj.com/content/early/2013/05/20/annrheumdis-2012-203090.full.pdf. [Last accessed February 2015].
[8] Park W, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. 2013;72(10), 1605-12. Available at: http://ard.bmj.com/content/early/2013/05/16/annrheumdis-2012-203091.full. [Last accessed February 2015].