Biosimilars: An Update on Clinical Trials (Review of Published and Ongoing Studies)

Biosimilars represent a new trend in the treatment of many immune-mediated inflammatory diseases. Regulatory requirements for approval of biosimilars are different from those of originators and rely mostly on the evidence generated from bioequivalence studies and in particular from RCTs. Our goal in this review was to search for relevant studies from randomized controlled trials on the biosimilars adalimumab, etanercept, infliximab and ustekinumab compared with their reference medication (publication in Medline) and ongoing studies in clinical trial registries. For infliximab biosimilars, we found data on patients with ankylosing spondylitis rheumatoid arthritis indicating no clinically relevant differences regarding efficacy and safety, as well as data on inflammatory bowel diseases and psoriasis. In addition, three registered studies of adalimumab biosimilars and just one study of an etanercept biosimilar were being carried out in patients with psoriasis. Ongoing studies on adalimumab, etanercept, and infliximab biosimilars in patients with rheumatoid arthritis were also identified. The conclusion seems to be that there are only 4 clinical trials on psoriasis (3 for the adalimumab biosimilar and 1 for etanercept biosimilar) and 1 clinical trial for Pso, CD, UC, RA, and AS (with the Infliximab biosimilar). Thus, the real and unique advantage of biosimilars is the low price derived from the special design studies despite the high technology used in fabrication process. Although not all ongoing biosimilar trials may have been registered, the present situation in terms of registered trials is quite unsatisfactory and provision of further clinical data and inclusion of patients in patient registries will be crucial.