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INCHEON, South Korea

Celltrion Healthcare welcomes the publication of the latest position paper from the European Crohn’s and Colitis Organisation (ECCO) on the use of biosimilars for inflammatory bowel disease (IBD), which supports switching from reference infliximab to biosimilar infliximab.¹

The ECCO statement covers several aspects related to biosimilars and the key positions are:¹

• Switching from the originator to a biosimilar in patients with IBD is acceptable following appropriate discussion between physicians, nurses, pharmacists, and patients, and according to national recommendation.
• When a biosimilar product is registered in the EU, it is considered to be as efficacious as the reference product when used in accordance with the information provided in the Summary of Product Characteristics.
• Demonstration of safety of biosimilars requires large observational studies with long-term follow-up in IBD patients.
• Data for the usage of biosimilars in IBD can be extrapolated from another sensitive indication.
• As for all biologics, traceability should be based on a robust pharmacovigilance system.

This marks a significant shift in attitude from the previous ECCO position paper, which advised that switching from an established biologic to a biosimilar was inappropriate and called for more data on the safety and benefit of biosimilars in general.²

Professor Silvio Danese, President Elect of ECCO and Head of the IBD Unit, Humanitas Clinical and Research Center, Italy commented: “Findings from the 2015 ECCO survey of IBD specialists found that around 80% of specialists are either totally confident, very confident or confident enough in using biosimilars, which is a huge change compared to 39% when a similar survey was conducted back in 2013.”³

Man Hoon Kim, President and CEO of Celltrion Healthcare, said: “This position paper comes amid a global trend encouraging the use of biosimilars. Rising healthcare costs and the consequent financial burden placed on health services are some of the biggest challenges many countries face. While biologics have positively impacted patient treatment, their high costs may limit patient access to these modern medicines. The availability of generally less expensive treatment options like biosimilars can reduce pressure on healthcare system resources.

Biosimilars are a cost effective alternative to biological therapies and can eventually lead to potential budget savings and provide improved access to life-changing treatment for patients.”

Real-world data in support of CT-P13

Celltrion Healthcare has already seen success with CT-P13 – the world’s first monoclonal antibody biosimilar approved by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The recently released NOR-SWITCH study revealed that efficacy and safety were maintained in patients switched to CT-P13 from originator infliximab and it is not inferior to those who continued treatment with the originator.⁴ These findings were presented at the 2016 United European Gastroenterology (UEG) Week in October and at the 2016 American College of Rheumatology (ACR) Annual Meeting in November.

— Ends—

Notes to editors:

About European Crohn´s and Colitis Organisation (ECCO)

The European Crohn´s Colitis Organisation (ECCO) is the non-profit association founded in 2001 to improve the care of patients with inflammatory bowel disease (IBD) in Europe. ECCO is the largest forum for specialists in IBD in the world, representing 3,132 IBD experts as individual members. ECCO develops clinical guidelines that serve as standard references for IBD management in Europe. The first position statement of ECCO on the use of biosimilar medicines in the treatment of IBD was published in 2013 to define the collective view of European specialist in IBD concerning biosimilars.

About biosimilar infliximab (CT-P13)

The biosimilar infliximab developed and manufactured by Celltrion, Inc. was the world’s first biosimilar monoclonal antibody to be approved by the European Medicines Agency (EMA). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and inflammatory bowel disease. It was approved by the EMA under the trade name Remsima^® in September 2013 and launched in Europe in early 2015. The US FDA approved Celltrion’s biosimilar infliximab in April 2016 under the trade name Inflectra™. Celltrion’s biosimilar infliximab is approved in more than 75 (as of September 20, 2016) countries including the US, Canada, Japan and throughout Europe.

About inflammatory bowel diseases

Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic disabling gastrointestinal disorders that impact every aspect of a patient’s life.⁵ They affect an estimated 2.5-3 million people in Europe;⁶ CD affects about three people per 1,000 and UC about five people per 1,000.⁵

IBDs account for substantial costs to the healthcare system and society; the direct healthcare costs of IBDs are estimated to be €4.6-5.6 billion per year.⁶

About Celltrion Healthcare

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

References

¹ Danese S., et al. (2016) ECCO Position Statement on the Use of Biosimilars for Inflammatory Bowel Disease—An Update. Journal of Crohn’s and Colitis. 1–9 doi:10.1093/ecco-jcc/jjw198

² Danese S., et al. (2013) ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD). Journal of Crohn’s and Colitis. 7(7):586-9. doi: 10.1016/j.crohns.2013.03.011.

³ Danese S., et al. (2016) Changes in biosimilar knowledge among European Crohn’s Colitis Organization (ECCO) members. A updated Survey. Journal of Crohn’s and Colitis. DOI: http://dx.doi.org/10.1093/ecco-jcc/jjw090

⁴ Kvien, T. et al Biosimilar Infliximab (CT-P13) is Not Inferior to Originator Infliximab: Results from a 52-Week Randomized Switch Trial in Norway. American College of Rheumatology (ACR) 2016; 19L.

⁵ Molodecky, Natalie A., et al. (2012) Increasing Incidence and Prevalence of the Inflammatory Bowel Diseases With Time, Based on Systematic Review. Gastroenterology, 142(1). doi:10.1053/j.gastro.2011.11.016

⁶ Burisch J, et al. (2013)The burden of inflammatory bowel disease in Europe. Journal of Crohn’s and Colitis. 7(4), 322-337.

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