CelltrionHealthcare

20 February 2015, Barcelona, Spain, Celltrion Healthcare has today announced data demonstrating that the world’s first biosimilar monoclonal antibody (mAb) infliximab is an effective treatment option for patients with the chronic debilitating autoimmune diseases, Crohn’s disease (CD) and ulcerative colitis (UC).[1]^,[2] Clinical experience of biosimilar infliximab in 332 patients with inflammatory bowel disease (IBD) is being presented in six posters and a satellite symposium at ECCO 2015 showing that the treatment is effective and safe in these patients. The safety and efficacy of biosimilar infliximab in rheumatoid arthritis (RA) and ankylosing spondylitis (AS) have previously been demontrated in two pivitol clinical trials, PLANETAS and PLANETRA.[3]^,[4] Biosimilar infliximab, developed by Celltrion, Inc, is approved by the EMA for treatment of eight autoimmune diseases, including adult and pediatric CD and UC.[5]

Six posters show clinical experience with biosimilar mAb infliximab

Data from six prospective observational trials, totalling 258 patients from Europe and South Korea, show that the biosimilar infliximab is an effective and well-tolerated treatment for patients with CD and UC.^1,2,[6],[7]^,[8]^,[9]

In one study of 106 patients with CD or UC, the clinical response to the treatment at 8 weeks was ≥87% in patients who had not been treated with anti-tumor necrosis factor (anti-TNF) therapy before and ≥67% in patients who had switched from another anti-TNF therapy.¹ Another study, in which data was collected prospectively on 90 patients with CD or UC, demonstrated decreases in internationally recognized scores of disease activity after 6 weeks of treatment with the biosimilar mAb infliximab (CRP level [from 23l5mg/L to 11.3mg/L at 2 weeks and 15.3mg/L at week 6], CDAI [compared to baseline p<0.001, ANOVA-Scheffe] and pMAYO score [from 6.4 to 3.7 at week 2 and 3.6 at week 6]).²

Case report from Norway

At a satellite symposium session, Jørgen Jahnsen, Professor of Gastroenterology at the University of Oslo, Norway, reported on his clinical experience of treating CD and UC patients with biosimilar mAb infliximab. A reduction in disease activity at week fourteen was reported in 74 IBD patients (44 CD and 30 UC): after three infusions of biosimilar infliximab, there was a significant reduction in HBI, calprotectin and CRP in CD patients, and in partial MAYO score, Simple AI, calprotectin and CRP in UC patients.

Stanley Hong, President of Celltrion Healthcare, said: “The data presented at ECCO’s 2015 congress support the EMA’s decision to approve the biosimilar infliximab for the treatment of Crohn’s disease and ulcerative colitis in the EU based on extrapolation of the clinical data in rheumatologic diseases which demonstrated comparable efficacy and safety to its reference medicinal product. We are conducting prospective observational and registry trials as part of pharmacovigilance in the EU and South Korea to monitor the safety of the biosimilar infliximab.”

Biosimilar mAb infliximab posters at ECCO

The following abstracts relating to the efficacy and safety of the biosimilar infliximab in CD and UC are being presented at ECCO 2015:

Suk JY, et al. Efficacy and safety of infliximab's biosimilar (Remsima) for IBD. P540.

Gecse K, et al. Biosimilar infliximab in inflammatory bowel diseases: first interim Results from a prospective nationwide observational cohort. P314.

Jarzebicka D, et al. Preliminary assessment of efficacy and safety of switching between originator and biosimilar infliximab in paediatric Crohn disease patients. P295.

Sieczkowska J, et al. Assessment of safety and efficacy of biosimilar infliximab in children with Crohn disease: a preliminary report. P430.

Jarzebicka D, et al. First observations of the use of biosimilar infliximab for treatment of ulcerative colitis in paediatric population. P456.

Molnar T, et al. Efficacy of the new infliximab biomarker CT-P13 induction therapy on mucosal healing in ulcerative colitis patients. P603.

Celltrion Healthcare satellite symposium

Satellite symposium 3a: Remsima™, the 1st biosimilar monoclonal antibody, Friday 20 February 07:15-08:15

• Real world experience in IBD, Jørgen Jahnsen, Professor of Medicine and Gastroenterology at the University of Oslo

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Notes to editor

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.[10] They affect and estimated 2.5-3 million people in Europe;[11] CD affects about three people per 1,000 and UC about 5 people per 1,000.⁸

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.⁹

About the biosimilar mAb infliximab Remsima™

Remsima™ is a biosimilar of the reference medicinal product (RMP) Remicade (infliximab). It is an anti-TNF mAb that is used to reduce inflammation and improve other symptoms of the diseases for which it is indicated.³

Remsima™ is approved by the EMA for the treatment of the autoimmune diseases, RA, AS, CD, paediatric CD, UC, paediatric UC, psoriasis, and psoriatic arthritis.³

Clinical trials have demonstrated comparability of Remsima™ in quality, safety and efficacy to its RMP.³

About biosimilars

Biosimilars are rigorously assessed through pre-clinical and clinical trials to demonstrate comparability in quality, safety and efficacy to their RMP.[12]

Since their introduction over 15 years ago, biologics have positively impacted patient treatment. However, the high cost of their use places a considerable burden on healthcare systems, which may affect patient access to treatment.[13]

Biosimilars have the potential to offer cost savings to health services,[14] particularly as they are often used to treat long-term conditions. Research has shown that, between 2007 and 2020, the use of biosimilar mAbs is expected to result in savings ranging from €1.8 to €20.4 billion.^[15]

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/