Studies Demonstrate Remsima Efficacy and Safety Following Switch from Infliximab

March 21, 2016
BioPharm International Editors

The studies, conducted across eight countries with nearly 600 inflammatory bowel disease (IBD) patients, further support claims by Celltrion that Remsima is highly similar its reference product.

A total of 10 real-world studies of Celltrion’s Remsima (infliximab) show comparable efficacy and safety following a switch to the company’s biosimilar infliximab from the reference product, it said in a March 18, 2016 press release. The studies, conducted across eight countries with nearly 600 inflammatory bowel disease (IBD) patients, further support claims by Celltrion that Remsima is highly similar its reference product, Remicade, marketed by Johnson & Johnson in the United States.

There has been some discussion over the use of biosimilars for the treatment of IBD. Health Canada, who approved the drug for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ankylosing spondylitis (AS), psoriatic arthritis (PsA), and plaque psoriasis, left out Crohn’s disease and ulcerative colitis based on uncertainty surrounding the small differences in antibody-dependent cellular cytotoxicity (ADCC). By comparison, European Medicines Agency (EMA) approved the drug for all of the reference product indications.

The 10 studies, presented at the 11th Congress of the European Crohn’s and Colitis Organization (ECCO) and referenced by Celltrion, provide clinical evidence that Remsima is an effective treatment for IBD. According to the company, the results of the biosimilar infliximab switching studies are further supported by two long-term follow up studies presented at Celltrion Healthcare’s satellite symposium. The extension studies of PLANETAS and PLANETRA 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.

According to Celltrion, as familiarity has grown with the drug, so has confidence in monoclonal antibody biosimilars. A recent survey conducted on ECCO members showed that confidence in biosimilars has been increasing. The survey shows that only 19.5% of respondents feel little or no confidence in the use of biosimilars monoclonal antibodies, compared with 61% of respondents in a 2013 survey.  

“Biosimilar infliximab was the first monoclonal antibody to become available so there was some understandable trepidation around the time of launch,” said Professor Silvio Danese, head of the IBD Center at the Istituto Clinico Humanitas and lead author of the survey, in a statement. “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.”

Source: Celltrion