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Celltrion Healthcare: Norwegian government’s independent NOR-SWITCH study supports switching to biosimilar infliximab from originator

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New data presented at the 2016 United European Gastroenterology (UEG) Week show that a switch to biosimilar infliximab (CT-P13) from originator infliximab is not inferior to continued treatment with the originator and that patients can be safely switched.1

The clinical study, sponsored by the Norwegian government, involved nearly 500 patients at 40 sites across Norway who had been on stable infliximab treatment for at least six months. The patients were living with chronic inflammatory diseases: Crohn’s disease, ulcerative colitis, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis or chronic plaque psoriasis.1

Approximately half of the patients were switched to Celltrion Healthcare’s biosimilar infliximab (CT-P13) and the findings show that efficacy and safety were comparable between this group and those who remained on the originator. They also indicate that the time to study drug discontinuation was almost identical between the two groups.1 Further data presented at UEG Week on remission rates in Crohn’s disease and ulcerative colitis show that the remission rate with biosimilar infliximab (CT-P13) was comparable to the originator.1

Jørgen Jahnsen, Professor of Gastroenterology at the University of Oslo, Norway, and co-author of the NOR-SWITCH study, said: “We conducted this study to assess how switching to biosimilar infliximab affects patients who are stable on the originator biologic. The data shows that safety and efficacy are maintained post-switch and should give confidence to physicians looking to move their patients onto biosimilar infliximab for non-medical reasons such as cost. I am hopeful that switching will lead to financial savings that can in turn enable more patients to receive this life-changing medicine.”

Real-world data in support of biosimilar infliximab

The positive results of the NOR-SWITCH study build on a growing body of real-world data that support the safety and efficacy of biosimilar infliximab (CT-P13). A number of real-world studies were presented at UEG Week,2,3,4,5,6,7,8 including a tertiary centre study of a cohort of anti-TNF naïve patients with inflammatory bowel disease (IBD) which concluded that both efficacy and safety of biosimilar infliximab (CT-P13) were comparable to that observed previously with originator infliximab.5

An Italian study presented at a Celltrion Healthcare satellite symposium during the congress involving 547 IBD patients in 31 referral centres, concluded that biosimilar infliximab (CT-P13) is as safe and effective as the originator. There was no increase in infusion reactions or loss of response in patients who were switched to biosimilar infliximab (CT-P13) from the originator.9

Cost-competitive drugs can lead to increased access for patients

Real-world cost savings associated with the use of biosimilar infliximab (CT-P13) were studied in five European countries: Germany, France, Italy, Spain and UK. According to new data presented at UEG Week, total cost savings in 2015 ranged from €1.35 million in Germany to €5.97 million in Spain. The Spanish findings suggest that use of biosimilar infliximab (CT-P13) could allow up to 1,085 extra patients per year to access biologic therapy. There were no cost savings in France, as the price of biosimilar infliximab (CT-P13) and originator were the same.10

Man Hoon Kim, President and CEO of Celltrion Healthcare, said: “Now more than ever, healthcare systems around the world are under pressure to reduce spending. I applaud the Norwegian government for this landmark study which will enable them to reduce healthcare costs in the confidence that patients switched to biosimilar infliximab will experience efficacy and safety comparable to the originator.”

“The NOR-SWITCH study builds on a wealth of data that support appropriate switching of patients to biosimilar infliximab, with new studies being presented all the time. At Celltrion Healthcare, we are proud that our biosimilar may enable more people with chronic inflammatory conditions to benefit from infliximab.”

--- Ends---

Notes to editors:

About the NOR-SWITCH study

The Norwegian government wanted to determine the impact of switching adult patients who were stable on originator infliximab to the biosimilar (CT-P13), and funded NOR-SWITCH to evaluate this across all inflammatory diseases for which infliximab is approved.

The study was designed by a multidisciplinary and multiregional project group with special competence in performance of strategy trials, immunogenicity, and statistics led by Professor Tore Kvien at the Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. Additionally, the group consisted of representatives from the three relevant patient organisations.11

Real world data for biosimilar infliximab presented at UEG Week 2016

  • OP142 A. Bálint, et al. Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort.
  • OP145 K. Gecse, et al. Efficacy and safety of biosimilar infliximab after one year: results from a prospective nationwide cohort.
  • P0301 B. Lovasz, et al Immunogenicity profile and predictors of TLS and ADA development of biosimilar infliximab during the first 6 months of the therapy: Results from a prospective nationwide cohort.
  • P0864 K. Malickova, et al. No difference in immunogenicity of the original and biosimilar infliximab in patients with inflammatory bowel disease.
  • P0872 M. Bortlik, et al. Biosimilar infliximab is effective and safe in inflammatory bowel disease patients naïve to anti-TNF therapy: A tertiary centre experience.
  • P1410 M. Kolar, et al. Switching of patients with inflammatory bowel disease from original infliximab (Remicade®) to biosimilar infliximab (Remsima™) is effective and safe – One year follow-up.
  • P1426 T. Molnar, et al. Efficacy of infliximab biosimilar CT-P13 induction therapy on mucosal healing in ulcerative colitis.
  • P1431 K. Farkas, et al. Infliximab biosimilar CT-P13 therapy is effective in maintaining clinical and endoscopic remission in Crohn's disease and ulcerative colitis - Experiences from a single center.

Pharma-economic data for biosimilar infliximab presented at UEG Week 2016

  • OP146 F. Rencz, et al. Cost-utility of biosimilar infliximab (inflectra©) for the treatment of luminal Crohn's disease in nine European countries.
  • P0336 S. Han, et al. Five year budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of Crohn's disease and ulcerative colitis in Spain.
  • P0860 S. Han, et al. Pharmacoeconomic analysis of biosimilar infliximab (CT-P13) in five European countries in 2015.
  • P1394 P. Baji, et al. Cost-utility of biosimilar infliximab for the treatment of fistulising Crohn's disease in nine European countries.

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.12 They affect an estimated 2.5-3 million people in Europe;13 CD affects about three people per 1,000 and UC about 5 people per 1,000.12

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.13

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/

About biosimilar infliximab

The biosimilar infliximab (CT-P13) 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 (CT-P13) in April 2016 under the trade name Inflectra™. Celltrion’s biosimilar infliximab (CT-P13) is approved in more than 75 (as of September 20, 2016) countries including the US, Canada, Japan and throughout Europe.

References

1 Jørgensen, K. et al. Biosimilar infliximab (ct-p13) is not inferior to originator infliximab: Results from the 52-week randomized NOR-SWITCH trial. United European Gastroenterology Week (UEGW) 2016; LB15

2 Bálint, A. et al. Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: Results from Central European nationwide cohort. United European Gastroenterology Week (UEGW) 2016; OP142.

3 Gecse, K. et al. Efficacy and safety of biosimilar infliximab after one year: results from a prospective nationwide cohort. United European Gastroenterology Week (UEGW) 2016; OP145.

4 Malickova, K. et al. No difference in immunogenicity of the original and biosimilar infliximab in patients with inflammatory bowel disease. United European Gastroenterology Week (UEGW) 2016; P0864.

5 Bortlik, M. et al. Biosimilar infliximab is effective and safe in inflammatory bowel disease patients naïve to anti-TNF therapy: A tertiary centre experience. United European Gastroenterology Week (UEGW) 2016; P0872

6 Kolar, M. et al. Switching of patients with inflammatory bowel disease from original infliximab (Remicade®) to biosimilar infliximab (Remsima™) is effective and safe – One year follow-up. United European Gastroenterology Week (UEGW) 2016; P1410

7 Molnar, T. et al. Efficacy of infliximab biosimilar ct-p13 induction therapy on mucosal healing in ulcerative colitis. United European Gastroenterology Week (UEGW) 2016; P1426

8 Farkas, K. et al. Infliximab biosimilar ct-p13 therapy is effective in maintaining clinical and endoscopic remission in Crohn's disease and ulcerative colitis - Experiences from a single center. United European Gastroenterology Week (UEGW) 2016; P1431

9 Fiorino, G et al. prospective observational study on safety and efficacy of infliximab biosimilar in patients with inflammatory bowel disease: results from the PROSIT-BIO cohort. Celltrion Healthcare satellite symposium. United European Gastroenterology Week (UEGW) 2016;

10 Han, SJ. et al. Pharmacoeconomic analysis of biosimilar infliximab (CT-P13) in five European countries in 2015. United European Gastroenterology Week (UEGW) 2016; P0860.

11 GAFPA. NOR-SWITCH. Available at: http://1yh21u3cjptv3xjder1dco9mx5s.wpengine.netdna-cdn.com/wp-content/uploads/2016/09/GAfPA_Norswitch_Sept.-2016.pdf [accessed October 2016].

12 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 www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [accessed October2016].

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

Contact information

Hanover Communications for Celltrion Healthcare
Suru Douglas
sdouglas@hanovercomms.com
+44 203 817 6586
or
Sophie Bryant
sbryant@hanovercomms.com
+44 203 817 6761

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