Celltrion Healthcare Present 1-year Results for CT-P13 (Biosimilar Infliximab, Remsima®/ Inflectra®) Switching Study in Crohn’s Disease

CT-P13 shown to be comparable in efficacy and safety to reference infliximab in switched inflammatory bowel disease patients

CT-P13 shown to be well-tolerated in subcutaneous form

BARCELONA, Spain--(BUSINESS WIRE)--Today at the 25^th United European Gastroenterology Week Congress, Celltrion Healthcare presented data from the phase III, randomised controlled, switching trial comparing CT-P13 and reference infliximab. The data showed comparable efficacy and safety between all treatment groups (maintained and switched) in patients with moderate to severe Crohn’s disease (CD) up to one year.¹

The trial investigated the efficacy and safety of CT-P13 throughout a 54-week treatment period, following a switch from reference infliximab at week 30. 220 patients were randomly assigned to four groups (maintained groups [CT-P13 and reference infliximab] and switched groups [reference infliximab to CT-P13 and CT-P13 to reference infliximab]) in a double-blinded manner. Efficacy, pharmacokinetics (PK) and safety were comparable among all treatment groups up to week 30.² The Crohn’s Disease Activity Index - 70 (CDAI-70) response, clinical remission and the Short Inflammatory Bowel Disease questionnaire (SIBDQ) score, a measure of quality of life for people with inflammatory bowel disease, were similar among all groups at each measured time point up to week 54 too.¹

The safety profiles among all treatment groups, including adverse reactions, serious adverse events, infections, and immunogenicity were similar throughout the one year treatment period.¹

Professor Stefan Schreiber, Director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany, commented on the study, “This is the next randomised controlled trial following the NOR-SWITCH study in patients with inflammatory bowel disease using CT-P13 infliximab that shows positive results. All treatment groups in this study, including reference infliximab maintenance, CT-P13 infliximab maintenance, and switching in both directions (reference to CT-P13 and CT-P13 to reference) groups showed comparable efficacy and safety. As a gastroenterologist, I find these data reassuring and hope they help my fellow physicians make informed treatment decisions to ensure the best outcomes for their patients.”

Improving patient treatment experience of CT-P13

Celltrion Healthcare also presented data from an initial phase I open label study of a subcutaneous (SC) form of CT-P13 in healthy volunteers. The study was designed to evaluate the safety and PK of CT-P13 SC. Results showed PK profiles after a single SC injection were linear by dose levels. Subcutaneous administration of CT-P13 was found to be feasible in terms of bioavailability and safety profile and could provide patients with a more convenient and accessible treatment administration option.³

Man Hoon Kim, President and CEO of Celltrion Healthcare, said, “Active switching to biosimilars could have a significant impact on the financial sustainability of healthcare systems by generating budget savings for biologic treatments. This switching study in Crohn’s disease is important in showing clinical evidence of the comparable safety and efficacy when switching to biosimilars. Adding to the wealth of data for CT-P13, Celltrion Healthcare is confident that these results should help physicians to feel even more confident in switching between reference products and biosimilars and is committed to continuously providing more convenient treatment options, including the subcutaneous form of infliximab to patients.”

Notes to editors:

About inflammatory bowel disease

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.⁴ They affect an estimated 2.5-3 million people in Europe;⁵ CD affects about three people per 1,000 and UC about 5 people per 1,000.⁴

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.⁵

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 CT-P13 3.4 CD RCT

The study is a randomised, double-blind, parallel-group, phase III study to investigate the efficacy and safety of CT-P13 compared to reference infliximab in people with Crohn’s disease. Out of 220 patients randomised in 58 study centres across 16 countries, 214 patients completed up to week 6 for the primary analysis and 180 patients completed up to week 30. At week 30 approximately half of the patients in each group were switched to the alternative treatment up to 54 weeks. 166 patients completed the study to 54 weeks. The study was funded equally by Celltrion and Pfizer.

About CT-P13 (biosimilar infliximab)

CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Medicines Agency (EMA). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and IBD. 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 CT-P13 in April 2016 under the trade name Inflectra™. CT-P13 is approved in more than 80 countries (as of October 2017) including the US, Canada, Japan and throughout Europe.

¹ Kim YH, et al. LB04, Phase III randomized controlled trial to compare biosimilar infliximab (CT-P13) with innovator infliximab in patients with active Crohn’s disease: 1-year maintenance and switching results. Presented at the 25th United European Gastroenterology Week Congress.
² Kim YH, et al. Phase III randomized double-blinded, controlled trial to compare biosimilar infliximab (CT-P13) with innovator infliximab (INX) in patients with active Crohn’s disease: early efficacy and safety results. Gastroenterology 152, S65 (2017).
³ R. Westhovens et al. P0387, Subcutaneous administration of a novel formulation of CT-P13 (Infliximab biosimilar) is safe and achieves projected therapeutic drug levels: a phase Ⅰ study in healthy subjects, Presented at the 25th United European Gastroenterology Week Congress.
⁴ 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 [Last accessed January 2017].
⁵ Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.