Research Indicates Biosimilar-to-Biosimilar Switching in Chronic Inflammatory Diseases Safe

A systematic compilation of studies assessing the clinical efficacy and safety of biosimilar-to-biosimilar switch in chronic inflammatory diseases published in Frontiers in Pharmacology provides evidence that switching between biosimilars is safe and effective, supporting the use of biosimilars to decrease costs and improve access to biological medicines. 

While there is evidence supporting the effectiveness and safety of switching from originators to biosimilars, concerns remain among scientific societies and regulatory agencies, making it necessary to further evaluate the evidence and address these concerns for widespread acceptance and implementation of biosimilar switching. 

Studies from 2021 to March 2022 were pulled from MEDLINE, Embase, and the Cochrane Library. Studies related to the clinical efficacy and safety of biosimilar-to-biosimilar switch in chronic inflammatory diseases such as Crohn's disease and ulcerative colitis. Researchers especially focused on anti-TNF agents, as there are multiple biosimilars available for infliximab, adalimumab, and etanercept in the EU. Anti-TNF agents are also the focus of various initiatives in different countries to increase the utilization of their biosimilars, resulting in significant cost reductions and savings in healthcare expenditures.  

The search strategy employed three categories of keywords related to switch/substitution, biological medicine/biosimilar, and anti-TNF agents, and the retrieval and extraction of relevant information from eligible studies were conducted by one reviewer (EA) and verified by a second reviewer (RB). The findings of the studies were described narratively. 

Researchers analyzed 19 studies (18 were clinical). These studies did not directly compare switching from one biosimilar to another vs. maintaining the same biosimilar, but rather focused on comparing switching between biosimilars to switching from the originator to a biosimilar or multiple switches. Most of the studies involved infliximab and assessed its use for inflammatory bowel diseases. Overall, the studies suggest that switching between biosimilars is safe and effective in terms of disease activity, remission rate, adverse events, and immunogenicity. The lack of studies comparing the switching between biosimilars and maintaining the same biosimilar highlights the need for further research to address concerns about switching.  

“Overall, these studies did not highlight significant concerns in switching between biosimilars,” said researchers. “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.” 

Reference  

Eleonora A, Brian G, Marco G, et al. Switching among biosimilars: A review of clinical evidence. Frontiers in Pharmacology. 2022;13. doi:10.3389/fphar.2022.917814