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Biosimilars: A Review of Published Randomized Control Trials Comparing Biosimilars with their Reference Products

Rodica Olteanu, Magda Constantin and Alexandra Zota

Biosimilars represent a therapeutic revolution for many immune-mediated inflammatory diseases. Biosimilars have different regulatory requirements than those of originators. These regulatory requirements are based on the evidence generated from bioequivalence studies, and in particular from RCTs. The goal of our review was to search for published randomized control trials that investigate biosimilars compared to their reference medicine (infliximab, adalimumab, etanercept, ustekinumab) in chronic inflammatory diseases (psoriasis, psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative cholitis, by using the Medline (PubMed) databases. Nineteen randomized control trials investigating biosimilars compared to their reference drug were included. As of November 2017, five anti-TNF biosimilar agents have been granted approval and are available on the market for patients with as inflammatory disease in the European Union. The Infliximab biosimilars CT-P13 (Remsima, Inflectra) and SB2 (Flixabi), the etanercept biosimilars SB4 (Benepali) and GP2015 (Elrezi) and adalimumb biosimilars ABP501 (Amgevita, Solymbic), SB5 (Imraldi) and BI 695501(Cyltezo). Evidence of equivalence between biosimilars and reference drugs was supported by head-to-head randomized clinical trials: two published randomized clinical trials for SB2, SB4, GP2015, ABP501, SB5, BI695501 and three published randomized control trial in the case of CT-P13 and ABP 501. Although not all randomized clinical trials comparing biosimilar to its reference product have been published, the present situation is satisfactory and provision of further clinical trials awaited.