CelltrionHealthcare

Physician view of monoclonal antibody biosimilars increasingly positive

as real-world evidence and experience grows[1]

18^th March 2016, Amsterdam, Netherlands. Real-world studies with nearly 600 inflammatory bowel disease (IBD) patients in eight countries show comparable efficacy and safety following a switch to biosimilar infliximab from originator infliximab.[1-10] These studies, presented at the 11^th Congress of the European Crohn’s and Colitis Organisation (ECCO), further support the appropriate switching of patients to Remsima®, a cost-effective alternative to originator infliximab, and build on the wealth of real-world evidence of the safety and efficacy of Remsima® accumulated since its launch a year ago.

As physician experience with biosimilar infliximab has grown, so has confidence in monoclonal antibody biosimilars. The results of a survey of ECCO members presented at the ECCO congress show that only 19.5% of respondents feel little or no confidence in the use of biosimilar monoclonal antibodies compared to 61% of respondents to a previous version of the survey undertaken in 2013.[11] The survey also shows that positive switching studies with biosimilar infliximab have helped to reassure physicians about switching from the originator, with 44.4% of respondents considering the originator and biosimilar to be interchangeable, compared with only 6% in the 2013 survey.

Professor Silvio Danese, head of the IBD Center at the Istituto Clinico Humanitas and lead author of the survey, said: “Biosimilar infliximab was the first monoclonal antibody to become available so there was some understandable trepidation around the time of launch. However, as people have been able to use the treatment, and with the large number of real-world and post-marketing studies now available, increasing numbers of clinicians are confident to use monoclonal antibody biosimilars. It is important that post-marketing and longer term studies with biosimilar infliximab are reported in order to further reassure clinicians and patients about biosimilars.”

The positive results of the biosimilar infliximab switching studies are further supported by two long-term follow up studies presented today at a Celltrion Healthcare satellite symposium. The extension studies of PLANETAS[2] and PLANTETRA[3] – the phase 3 trials that supported the approval of Remsima® – were performed to investigate the efficacy and safety of maintenance treatment with Remsima® over two years as well as the efficacy and safety of switching to Remsima® from originator infliximab for one year. Clinical efficacy, immunogenicity and safety were highly comparable between the maintenance and switch groups in both extension studies. Importantly, there were no signs of altered efficacy, safety or immunogenicity profiles following the switch to Remsima® from the originator. Furthermore, the proportion of immunogenicity-related safety events was similar between maintenance and switched rheumatoid arthritis and ankylosing spondylitis patients.

Man Hoon Kim, President and CEO of Celltrion Healthcare, said: “We know that physicians value real-world as well as clinical evidence and have worked hard to ensure these data are available. We now have a remarkable volume of data showing the comparable safety and efficacy of Remsima® in both treatment-naïve patients and those who have been switched to Remsima® from originator infliximab. We’re delighted to see a corresponding growth in physician confidence with monoclonal antibody biosimilars, and in willingness to switch to a biosimilar from the originator. This suggests that more patients will get the chance to benefit from biological therapies, particularly for conditions that require chronic treatment such as IBD.”

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Notes to editors:

About the switching studies

Further data for biosimilar infliximab presented at the 11^th Congress of ECCO

• OP003 P.A. Golovics, et al. Predicting short and medium-term efficacy of the biosimilar infliximab: trough levels/ADAs or clinical/biochemical markers play a more important role?

• DOP010 A. Bálint, et al. Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort.

• DOP028 K. Gecse, et al. Efficacy and safety of biosimilar infliximab after one year: results from a prospective nationwide cohort.

• DOP031 R. Bor, et al. Efficacy of infliximab biosimilar CT-P13 therapy on mucosal healing in ulcerative colitis – data from two Central European countries.

• DOP033 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.

• P311 D. Duricova, et al. No difference in immunogenicity of the original and biosimilar infliximab in patients with inflammatory bowel disease: Short-term results.

• P327 L. Carvalho Lourenço, et al. Biosimilar infliximab in real-life Crohn’s disease’s anti-TNF alpha naïve patients: a comparative observational cohort study (SIMRECRO study).

• P382 R. Muhammed, et al. Comparison of efficacy and safety of biosimilar infliximab to originator infliximab in children with inflammatory bowel disease.

• P484 P. Lakatos, et al. Access to biologics and biosimilars across 11 EU countries.

• P495 M. Bortlik, et al. Biosimilar infliximab is effective and safe in inflammatory bowel disease patients naïve to antiTNF therapy: a tertiary centre experience.

• P513 E. Zagorowicz, et al. Comparison of infliximab the originator and biosimilars in treatment of Crohn’s Disease: a Polish cohort study.

• P519 M. Kaniewska, et al. Efficacy and safety of biosimilar of infliximab (Inflectra) in adult patients with Crohn’s disease during one year of treatment followed by 6 months of observation – one centre retrospective study.

• P530 J. Sieczkowska, et al. Efficacy of biosimilar infliximab induction therapy in paediatric patients with Crohn’s Disease –1.5 years of experience.

• P577 N. Turk, et al. Croatian database from 5 centers – efficacy and safety of infliximab biosimilar in treatment of IBD patients.

• P645 M. Kaniewska, et al. Efficacy and safety of biosimilar of infliximab in rescue therapy in adult patients with severe ulcerative colitis.

About inflammatory bowel diseases

Inflammatory bowel diseases (IBD), includin