Editor-in-Chief, Deputy Editor 2017-2019

 

Editor-in-Chief:

Tom MOREELS

 

Deputy Editor:

Nicolas LANTHIER

 

Position document



Clinical and scientific aspects related to biosimilars in inflammatory bowel diseases Group (BIRD) (IBD) : position document of the Belgian IBD Research & Development


Price: €10,00

The management of chronic inflammatory disorders including inflammatory bowel diseases has been revolutionized by the entrance of biological agents now almost 20 years ago. Over 350 million of patients have been treated worldwide with biologicals. In Belgium, biologicals represent 26% of the total Belgian pharmaceutical budget both in the ambulatory settings and in the hospitals (53% are used in hospitals). In inflammatory bowel diseases (IBD), biological agents directed against TNF alpha are mainstay treatments for inducing and maintaining remission in moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC). Three anti-TNF agents have been approved by EMA for use in Crohn’s disease (infliximab and adalimumab) or ulcerative colitis (infliximab, adalimumab and golimumab). Eighteen years after the finalization of the pivotal trials, the patent for infliximab was the first to expire. Hence, biosimilars to infliximab are emerging on the market including for the treatment of IBD. Biosimilars are biological drugs which are similar to the authorized biologics (“reference product”) but not identical. Recently EMA has approved 2 biosimilars to infliximab on the basis of a rigorous and extensive comparability exercise in all characteristics via a development programme that included quality, nonclinical and clinical data including two clinical trials in rheumatology (ankylosing spondylitis and rheumatoid arthritis) (1). [Product Details...]