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Biosimilars in the therapy of inflammatory bowel diseases

Hlavaty, Tibor; Letkovsky, Juraj

European Journal of Gastroenterology & Hepatology: June 2014 - Volume 26 - Issue 6 - p 581–587
doi: 10.1097/MEG.0000000000000098
Review article

A biosimilar is a copy of an approved biological medicine whose patent protections have expired. Biosimilars of antibodies to tumour necrosis factor α (TNFα) are becoming important in the treatment of inflammatory bowel diseases (IBD). The first one introduced commercially is an infliximab biosimilar. The aim of this study was to provide an overview of anti-TNFα biosimilars. The literature on biosimilars of monoclonal anti-TNFα antibodies was reviewed, including their manufacture and approval pathways, concerns about efficacy, safety, immunogenicity, extrapolation, switching and labelling. Previous experience with biosimilars of epoetin and other growth factors was also reviewed. The infliximab biosimilar CT-P13 was the first biosimilar monoclonal antibody registered for the treatment of IBD. The major advantage of biosimilars is the reduced cost of therapy. Concerns have arisen, however, about the efficacy and safety of CT-P13 in IBD, the extrapolation of results from rheumatologic trials to IBD and the free interchangeability of CT-P13 with infliximab. Experience with simple peptide biosimilars, such as epoetins and growth factors, has generally been positive, with these biosimilars having similar efficacy and safety as the original products, although immunogenicity remains a major concern. Upcoming postregistration studies will address concerns on biosimilars in IBD, including their efficacy, safety, immunogenicity, switching and interchangeability. Biosimilars active against the same epitopes, but with improved pharmacokinetic properties that enhance their efficacy and/or safety, may be the next stage in the development of biosimilars. Anti-TNFα biosimilars represent promising new treatment options for patients with IBD. However, data on their efficacy and safety in IBD are needed.

Department of Internal Medicine, Division of Gastroenterology and Hepatology, University Hospital, Bratislava, Slovakia

Correspondence to Tibor Hlavaty, MD, PhD, Department of Internal Medicine, Division of Gastroenterology and Hepatology, University Hospital Bratislava, Ruzinovska 6, SK-82606 Bratislava, Slovakia Tel: +421 917 752 297; fax: +421 248 234 905; e-mail:

Received January 29, 2014

Accepted March 13, 2014

© 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins