Switching to Remsima®▼ (infliximab) from originator has no negative effect on safety or efficacy in 10 real-world studies

Switching to Remsima® (infliximab) from originator has no negative effect on safety or efficacy in 10 real-world studies

Physician view of monoclonal antibody biosimilars increasingly positive

as real-world evidence and experience grows

18th 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 11th 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 2013.11The 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[12] and PLANTETRA[13] – 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."