Biogen and Samsung Bioepis at United European Gastroenterology Week – the data ata highlights real-world evidence confirming the safety and efficacy of anti-TNF biosimilars for patients with inflammatory bowel disease (IBD)
Biogen Inc. and Samsung Bioepis presented new real-world data from the companies’ anti-TNF biosimilar portfolio, which includes FLIXABI™ (infliximab) and IMRALDI™ (adalimumab). These data, which provide further insight into the long-term safety and efficacy as well as patient experience with anti-TNF biosimilars, were presented at United European Gastroenterology (UEG) Week in Barcelona (October 19-23).
Four Biogen and Samsung Bioepis supported abstracts were presented at UEG Week 2019.
Data included a clinical evaluation of the switch from reference adalimumab to IMRALDI in 87 patients with IBD – either Crohn’s disease or ulcerative colitis. The study results showed an overall similar performance for the serum levels of adalimumab between IMRALDI and reference adalimumab. Moreover, symptom activity indexes and inflammatory markers remained consistent after switching to IMRALDI.
“We plan to continue to conduct research with the goal of generating data that will enable us to deliver value to patients with high unmet needs,” said Ian Henshaw, Vice President and Head of Biogen’s Global Biosimilars Unit.
An interim analysis of the non-interventional PERFUSE study will also be presented. This study investigated persistence (the number of patients continuing on treatment) and immunogenicity of FLIXABI in three subsets of IBD patients receiving FLIXABI. These interim results demonstrate high persistence on FLIXABI with no clinical differences observed (disease scores HBA or Simple Clinical Colitis Activity Index (SCCAI)) for the patients who transitioned.
“We remain committed to advancing our strong pipeline of biosimilar candidates, so that more patients and healthcare systems across the region will be able to benefit from biosimilars,” said Seongwon Han, M.D., Vice President and Lead of Medical Team, Samsung Bioepis.
In addition, early results from the IBISS study are reported. In this real-world cohort of IBD patients transitioning from one infliximab biosimilar (CT-P13) to another (FLIXABI), showed similar effectiveness and safety.
The fourth abstract focused on the personalization and optimization of therapeutic options.
FLIXABI™ (infliximab), a biosimilar referencing Remicade®, was approved by the European Commission (EC) in May 2016 for the treatment of adults with rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis or psoriasis. FLIXABI can also be used in patients 6–17 years old with severe, active Crohn’s disease or severely active ulcerative colitis when they have not responded to or cannot take other medicines or treatments. FLIXABI is currently available in 17 countries in Europe.
About IMRALDI™ (adalimumab)
IMRALDI™ (adalimumab), a biosimilar referencing Humira®, was approved by the European Commission (EC) in August 2017 for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondylarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis, pediatric uveitis. IMRALDI is currently available in 19 countries in Europe and is the leading adalimumab biosimilar in six European countries, such as Germany, Spain, Sweden, Poland, Denmark and Czech Republic. There are currently over 50,000 patients in Europe receiving treatment with IMRALDI.