Biosimilars of Adalimumab in Inflammatory Bowel Disease: Are we Ready for that?

Fiche publication


Date publication

janvier 2019

Journal

Current pharmaceutical design

Auteurs

Membres identifiés du Cancéropôle Est :
Pr PEYRIN-BIROULET Laurent


Tous les auteurs :
Argollo M, Fiorino G, Gilardi D, Furfaro F, Roda G, Loy L, Allocca M, Peyrin-Biroulet L, Danese S

Résumé

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.

Mots clés

Adalimumab, Crohn's disease, biosimilar, inflammatory bowel disease, monoclonal antibodies, ulcerative colitis.

Référence

Curr. Pharm. Des.. 2019 ;25(1):7-12