CELLTRION-HEALTHCARE

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Clinical experience of biosimilar infliximab in 78 inflammatory bowel disease (IBD) patients presented at Digestive Diseases Week (DDW) 2015 in Washington D.C. showed that the treatment is comparable to the reference medicinal product (RMP) in terms of efficacy and safety. Speaking at a satellite symposium hosted by Celltrion Healthcare, Jørgen Jahnsen, Professor of Gastroenterology at the University of Oslo, Norway, provided an update on his own clinical experience of treating patients with IBD in Norway with biosimilar infliximab, which represents the latest treatment development in IBD.

The clinical data from 46 Crohn’s disease (CD) and 32 ulcerative colitis (UC) patients presented at the meeting showed a statistically significant reduction in disease activity at week fourteen. Among them, 22 patients (8 UC and 14 CD) were previously treated with other biologics. Of the patients with CD, 76% (32/42) were in clinical remission (HBI score ≤4) at week 14 after three infusions of biosimilar infliximab, with significant reductions also seen in calprotectin and CRP. For UC patients, 56 % (18/32) were in clinical remission at week 14 (partial Mayo score ≤ 2) following the three infusions, with significant reductions in Simple Activity Index, calprotectin and CRP.

Professor Jahnsen said “Following approval of the first biosimilar monoclonal antibody by the FDA, there is excitement and anticipation for biosimilar infliximab to also be approved in the US. In Norway, our experience of biosimilar infliximab in patients with IBD over the past year shows that the safety and efficacy of the treatment is comparable to that of the reference medicine, while offering potential budget savings. We therefore expect that the availability of biosimilar infliximab could contribute to improving patient access to advanced biologic treatments.”

Meeting chair Walter Reinisch, Professor of Gastroenterology, McMaster University, Canada said: “It is exciting to see both the acceptance within the GI community, and the real-life benefits of biosimilar infliximab in Europe. Inflammatory bowel diseases are chronic disabling disorders that impact every aspect of a patient’s life and biosimilar infliximab is a new treatment option for patients with IBD.”

Discussions at the symposium focused on extrapolation of data and switchability and interchangeability of originator biologics and biosimilars. The speakers shared their experience with biosilmilars, explaining how extrapolation is inherent to the concept of biosimilarity and how interchangeability is widely accepted. The NOR-SWITCH Study, which will assess the safety and efficacy of switching from the RMP to biosimilar infliximab, was also discussed.¹ The study is being will be undertaken in 18 hospitals across in Norway and aims to recruit 500 people. Data from this study are expected in 2016.

Data from two posters on the safety and efficacy of biosimilar infliximab patients with CD and UC will be presented at DDW 2015.

• Preliminary assessment of efficacy and safety of switching between originator and biosimilar infliximab in paediatric Crohn disease patients. J Kierkus. Abstract Tu1081, Poster sessions Tuesday, May 19, 09:30-16.00 ET; Hall C.
• Biosimilar infliximab in inflammatory bowel diseases: first interim results from a prospective nationwide observational cohort. K. Gecse, et al. Abstract Tu1348, Poster sessions Tuesday, May 19, 09:30-16.00 ET; Hall C.

Celltrion’s biologics licence application for biosimilar infliximab is currently under review by the FDA. The timing of the FDA’s Arthritis Advisory Committee will be decided by the FDA and the meeting date will be announced in the Federal Register.

Dr Stanley Hong, President and CEO of Celltrion Healthcare, said: “The data presented at our satellite symposium further builds the evidence base for the efficacy of biosimilar infliximab in people with IBD. Many countries including the US suffer from increasing healthcare cost and we believe that a cost-effective treatment option like biosimilars will help substantially decrease the burden. As we await the results of the FDA's review of our application for the approval of biosimilar infliximab, we are happy to present real-world data at such an eminent global gastroenterology congress as DDW 2015.”

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Notes to editors:

About inflammatory bowel diseases (IBD)

Inflammatory bowel diseases (IBD), including Crohn’s disease and ulcerative colitis, are chronic disabling gastrointestinal disorders that impact every aspect of a patient’s life.² They affect and estimated 2.5-3 million people in Europe;³ CD affects about three people per 1,000 and UC about 5 people per 1,000.²

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.³

About biosimilar infliximab

The biosimilar infliximab developed and manufactured by Celltrion, Inc. is the world’s first biosimilar monoclonal antibody to be approved by the European Medicines Agency (EMA) for treatment of eight autoimmune diseases. It was approved by the EMA under the trade name Remsima® in September 2013 and launched in Europe in early 2015. It is currently being reviewed by the U.S. FDA.

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: www.celltrionhealthcare.com/

Celltrion Healthcare has established a vast distribution network of partners and experts who have in-depth knowledge and experience in their local markets. In European markets, Celltrion Healthcare is in partnership with the following companies:

• Astro Pharma: Austria
• Biogaran: France and Monaco
• DEMO S.A.: Cyprus
• Egis: Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Moldova, Bulgaria, Czech Republic, Latvia, Lithuania, Poland, Romania, Slovakia, Russia, Ukraine, Uzbekistan and Hungary.
• Hospira: Europe
• Kern Pharma: Spain
• Medical Logistics: Malta
• Mundipharma: Belgium, Germany, Italy, Luxembourg, the Netherlands and the UK (Napp)
• Oktal Pharma d.o.o. : Slovenia, Croatia, Bosnia-Herzegovina and Serbia
• Orion: Denmark, Estonia, Finland, Norway, and Sweden
• PharmaKern: Portugal
• Pinewood: Ireland

References

¹ ClinicalTrials.gov. The NOR-SWITCH Study. Available at https://clinicaltrials.gov/show/NCT02148640 [Last accessed May 2015].

² Molodecky NA, et al . Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54. Available at http://www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed May 2015].

³ Burisch J, et al . The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.

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