Celltrion Healthcare: Data Show The World’s First European Medicines Agency-Approved Biosimilar Monoclonal Antibody Remsima Could Reduce Cost Of Treating Crohn’s Disease By Up To €336 Million Over Five Years

Cost savings could help improve patient access to life-changing treatment

BARCELONA, Spain--(BUSINESS WIRE)--Celltrion Healthcare has today announced data demonstrating the healthcare savings achievable by using Remsima™ (CT-P13), a biosimilar monoclonal antibody infliximab, to treat patients with Crohn’s disease (CD) in France, Italy and the UK.¹ The budget impact analysis, presented at the European Crohn’s and Colitis Organisation’s (ECCO) 10^th annual congress in Barcelona, Spain, shows that total five-year savings across the three countries ranged from €76 million to €336 million¹ in price discount scenarios tested.

“We are committed to helping improve patient access to medicines around the world. By developing Remsima™ we are giving physicians an additional drug choice for treating people with autoimmune diseases.”

Biosimilars have the potential to offer considerable cost savings to health services,¹ particularly as they are often used to treat long-term conditions. Along with ulcerative colitis, CD accounts for substantial costs to the health care system and society.² Previous research has shown that, between 2007 and 2020, the use of biosimilar monoclonal antibodies (mAbs) is expected to result in savings ranging from €1.8 to €20.4 billion.³ The abstract concludes that the introduction of the biosimilar infliximab as a treatment option for patients with CD could achieve substantial cost savings.

“The data presented today show the clear cost savings that could be achieved by introducing Remsima™ for the treatment of Crohn’s disease. Remsima™ may offer physicians an alternative to other anti-tumor necrosis factor treatments. The savings with Remsima™ will help more patients have access to this treatment, and may mean they can receive it earlier in their disease.” said Dr. Alex Kudrin, Vice President at Celltrion, Inc.

Remsima™ is a biosimilar of the biologic medicine Remicade (infliximab), its reference medicinal product (RMP). It is an anti-tumor necrosis factor (anti-TNF) mAb that reduces inflammation and improves other symptoms of the diseases for which it is indicated.⁴ Clinical trials have demonstrated comparability of Remsima™ to its RMP in quality, safety and efficacy.⁵

Dr Stanley Hong, President of Celltrion Healthcare, said: “We are committed to helping improve patient access to medicines around the world. By developing Remsima™ we are giving physicians an additional drug choice for treating people with autoimmune diseases.”

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Notes to editor

• Inflammatory bowel disease (Crohn’s disease and ulcerative colitis) affects over 2.2 million people in Europe⁵
• Biosimilars are rigorously assessed in the laboratory and clinical trials to demonstrate the similar nature, in terms of quality, safety and efficacy, of the biosimilar and its approved reference medicinal product⁶
• A reference medicinal product is an approved biological medicine that contains the same active substance as the biosimilar.⁶

About the five year budget impact analysis¹

The five year budget impact analysis looked at three different scenarios to assess the potential situations that may occur with the introduction of Remsima™ in France, Italy and the UK. The model is based on the number of patients eligible for infliximab treatment out of the total population, taking into account annual population growth rate and prevalence of CD in France, Italy and the UK. The analysis was conducted based on the assumption that the ratio of patients receiving infliximab would not change in 2019.

About Remsima™

Remsima™ is a biosimilar of infliximab, an anti-TNF mAb that is used as an anti-inflammatory medicine in the treatment of eight autoimmune diseases. Remsima™ was granted marketing authorisation by the EMA in September 2013. Remsima™ will be launched in Europe on 25 February.

About Celltrion Healthcare

Celltrion Healthcare is a global biopharmaceutical company committed to delivering more affordable advanced therapeutics for patients. 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 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].

² Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn’s and Colitis (2013)7,322-337.

³ Saving money in the European healthcare systems with biosimilars. GaBI Journal. 2012;1(3-4).120-6. Available at: http://gabi-journal.net/saving-money-in-the-european-healthcare-systems-with-biosimilars.html#R13 [Last accessed February 2015].

⁴ 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].

⁵ European Federation of Crohn’s and ulcerative colitis associations. What is IBD? Available at: http://www.efcca.org/index.php/about-efcca/what-are-ibd. [Last accessed February 2015]

⁶ European Medicines Agency. Questions and answers on biosimilar medicines (similar biological medicinal products). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/12/WC500020062.pdf. [Last accessed February 2015].

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