Switching Among Biosimilars: A Review of Clinical Evidence

Abstract

Biological medicines have improved patients’ outcomes, but their high costs may limit access. Biosimilars, alternatives that have demonstrated high similarity in terms of quality, safety, and efficacy to an already licensed originator biological product, could increase competition and decrease prices. Given the expanding number of biosimilars, patients may switch from originator to biosimilar or among biosimilars. Randomized trials and observational studies conducted with multiple biosimilars over many disease areas confirmed the safety and efficacy of switching from originator to biosimilar. This study summarizes evidence on switching between biosimilars for which there are concerns to provide future guidance. A systematic search (MEDLINE, Embase, and Cochrane Library) for studies on anti-TNF agents, assessing clinical efficacy and safety of biosimilar-to-biosimilar switch in chronic inflammatory diseases, was performed. We retrieved 320 records and included 19 clinical studies. One study with historical control compared switching between biosimilars to maintenance of the same biosimilar. Ten were controlled cohort studies comparing switching between two biosimilars vs. switching from originator to a biosimilar or vs. multiple switches. Eight were single-arm cohort studies, where participants switched from one biosimilar to another, and the outcomes were compared before and after the switch. Overall, these studies did not highlight significant concerns in switching between biosimilars. Therefore, switching studies seem difficult to perform and unnecessary with the body of evidence suggesting no real problems in practice coupled with stringent regulatory requirements. Monitoring the use of biosimilars in clinical practice could support clinical decision-making, rational use of biological medicines, and help to further realize possible savings.

Biosimilar to Biosimilar Anti-VEGF Switching for Retinal Diseases

“…Allocati et al 2 performed an extensive evaluation of anti-tissue necrosis factor biosimilar agents. Of the 19 studies of biosimilar switching they analyzed, none directly compared biosimilar with biosimilar of a reference molecule.…”

Efficacy, safety and immunogenicity of etanercept biosimilars versus reference biologics in patients with rheumatoid arthritis: A meta-analysis

“…However, it is difficult to definitively state this since originator manufacturers do not need to conduct new studies following changes in manufacturing processes ( Vezér et al, 2016 ; Jiménez-Pichardo et al, 2017 ; Godman et al, 2020 ). Now the published studies address the lack of problems for patients switching between biosimilars, which is the next big hurdle to address in order to further accelerate biosimilar use ( Allocati et al, 2022 ).…”

Factors associated with the uptake of biosimilars for breast cancer treatment from the perspectives of physicians and patients-Evidence from China

“…Patients may mistakenly attribute these symptoms to biosimilars, further exacerbating their mistrust of biosimilars ( Gasteiger and Petrie, 2022 ). The weak intention of switching is a difficult question yet to be solved across countries ( Dutta et al, 2020 ; Allocati et al, 2022 ). To promote the uptake of biosimilars, one appropriate solution is to enhance educational policies for both patients and physicians.…”

“…Patients may mistakenly attribute these symptoms to biosimilars, further exacerbating their mistrust of biosimilars (Gasteiger and Petrie, 2022). The weak intention of switching is a difficult question yet to be solved across countries (Dutta et al, 2020;Allocati et al, 2022).…”