Abstract
The Psychological Risks Associated With the Non-medical Switch From Biologics to Biosimilars
Highlights
Biological products are therapeutic agents produced using a living system or organism
A quite cautious approach has been taken with regard to switching patients on the reference product to a biosimilar product, with differences across countries (La Noce and Ernst, 2018)
We must consider that, despite the evidence supporting the similarities between biosimilars and the reference drugs, some Italian and European surveys have indicated that prescribers do not have a strong understanding of the complex manufacturing process, approval requirements, or ongoing regulation of biologic and biosimilar products (Pasina et al, 2016; Cohen et al, 2017; O’Callaghan et al, 2017)
Summary
Biological products are therapeutic agents produced using a living system or organism. In 2018, for the first time, the AIFA report, starting from the demonstrated risk-benefit equality between the biosimilar drug and the reference originator drug, considered biosimilars as interchangeable with the corresponding reference originators (even living to the clinician the final decision and excluding the automatic shift) (Brogonzoli et al, 2018) In this regard, many Italian medical organizations, agreeing on their use in primary naïve patients, further remarked some concerns on the switch in patients with chronic or severe diseases, given that stable medication regimens are essential to effective disease management (ADOI, 2019; Dolinar et al, 2019). We close our contribution discussing the implications for clinical practice and public health, proposing some strategies to mitigate these potential risks in switching from a reference medicine to a biosimilar
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