The first study to comprehensively analyse post-marketing surveillance data for biosimilar monoclonal antibodies demonstrates comparable efficacy, safety and immunogenicity with the originator products .
A study published in Drugs  is the first to comprehensively analyse pre-licensing and long-term safety data, as well as data on immunogenicity and interchangeability, for biosimilar monoclonal antibodies and fusion proteins.
The study included biosimilars of adalimumab, bevacizumab, infliximab, rituximab, trastuzumab and etanercept approved in the EU before August 2020. Safety, immunogenicity and interchangeability data came from European Public Assessment Reports (EPARs), which are created by independent assessors and reflect the quality, efficacy and safety of medicinal products. Analysis of post-marketing safety was based on periodic safety update reports (PSURs); pharmacovigilance documents regularly submitted to the European Medicines Agency (EMA).
The analysis included six biosimilars of adalimumab, three of infliximab, three of etanercept, three of rituximab, two of bevacizumab, and six of trastuzumab. The results showed that the frequency of serious adverse events (SAEs), immune-mediated adverse events, treatment-emergent adverse events (TEAEs) leading to the discontinuation of treatment, and fatal TEAEs were comparable between biosimilars and their reference products.
Post-marketing surveillance analysis included up to seven years of follow-up and more than one million patient treatment years of safety data. It included information on estimated cumulative post-marketing patient exposure to each product; the safety of biosimilar monoclonal antibodies; changes to the safety information of products; risk minimization activities and the impact of new safety information on the benefit–risk ratio of each product.
The analysis did not identify any adverse effects specifically related to biosimilar use and no product was found to be withdrawn for safety reasons, despite use in treatment-naïve patients and those who had switched from the reference product.
Switching (a single time or multiple switches) between the reference product and a biosimilar was not found to have any negative impacts on efficacy, safety, or immunogenicity. The authors say that biosimilar monoclonal antibodies can therefore be safely administered in treatment-naïve patients or after switching from the reference product.
The authors conclude that biosimilar monoclonal antibodies licensed in the EU have comparable efficacy, safety and immunogenicity with their originator products. They say that systematic switching studies (which require hundreds of patients per study) are not required to support switching patients from reference products to biosimilars.
The authors go on to say that their results support the interchangeability of biosimilars licensed in the EU, suggesting that pharmacy-level substitution of these products is possible. They also discuss regulatory positions on the interchangeability of biosimilars, recommending that regulatory bodies across Europe agree on a common European position on interchangeability in order to promote the use of biosimilars.
Conflict of interest
The authors of the research paper  declared no competing interests.
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1. Kurki P, Barry S, Bourges I, et al. Safety, immunogenicity and interchangeability of biosimilar monoclonal antibodies and fusion proteins: a regulatory perspective. Drugs. 2021 Oct 1. doi: 10.1007/s40265-021-01601-2. Online ahead of print.
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