Marjorie Argollo, Gionata Fiorino*, Daniela Gilardi, Federica Furfaro, Giulia Roda, Laura Loy, Mariangela Allocca, Laurent Peyrin-Biroulet and Silvio Danese Pages 7 - 12 ( 6 )
Introduction: Biosimilars present a considerable potential to reduce costs related to clinical management allowing health-care providers to reinvest this money, leading to a wider access to an effective biological treatment with monoclonal antibodies (mAb). Infliximab biosimilars have already been incorporated in daily clinical practice and are currently used in all indications for which the reference product (RP) was approved.
Areas covered: In the next few years, also adalimumab biosimilars will become available for the treatment of inflammatory bowel disease (IBD). In fact, several of them (ABP501, BI 695501, GP2017, and SB5) have been approved by the European Medicines Agency (EMA) with the same indications of the reference product (Humira ®). Initial preclinical data proved a strong similarity between all biosimilars and the RP. Moreover, phase 3 studies in rheumatoid arthritis and psoriasis showed no differences in terms of efficacy, safety, and immunogenicity. Data on IBD patients are urgently needed.
Expert opinion: Biosimilars of adalimumab showed equivalent clinical efficacy to the RP in other immunemediated diseases. However, defining the ideal patient’s profile to receive or to be switched to a biosimilar, choosing one biosimilar vs. another, or cross-switching among biosimilars, will become the next challenge in IBD.
Adalimumab, biosimilar, Crohn's disease, inflammatory bowel disease, ulcerative colitis, monoclonal antibodies.
IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Institute, Rozzano, Milan, IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Institute, Rozzano, Milan, IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Institute, Rozzano, Milan, IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Institute, Rozzano, Milan, IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Institute, Rozzano, Milan, IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Institute, Rozzano, Milan, IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Institute, Rozzano, Milan, Department of Gastroenterology and Inserm U954, Nancy University Hospital, Lorraine University, Vandoeuvre, IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Institute, Rozzano, Milan