Biological products are therapeutic agents produced using a living system or organism. In many cases, access to these products is limited due to their expensive cost (Chow et al., 2011). A biosimilar is a biological product that is highly similar (not identic) to, and has no clinically meaningful differences from, an existing reference biological product on the market (Desai et al., 2020). “Non-medical” switching is the switching of a patient’s medicine for reasons other than the patient’s health and safety, like the reduction of costs (Dolinar et al., 2019). The therapeutic interchangeability and substitution of a biologic with the biosimilar product have recently increased its relevance for the scientific and political debate in Italy as in other European countries (Kurki et al., 2017; La Noce and Ernst, 2018; Dolinar et al., 2019). In Europe, substitution of a reference medicine with a biosimilar product is encouraged for treatment-naïve patients. However, 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). In Italy, such debate was alimented, among the others, by the position papers from the Italian Medicines Agency (AIFA) and several medical associations in the areas of rheumatology, gastroenterology, oncology, and nephrology (Brogonzoli et al., 2018; ADOI, 2019). One of the core issues of this debate is represented by the switch to a biosimilar in patients being treated with the reference biologic. As biosimilars are interchangeable, they can be expected to produce the same clinical result as the reference product in any given patient and, for a biologic product that is administered more than once, that the risk of alternating or switching between use of the biosimilar product and the reference product is not greater than the risk of maintaining the patient on the reference product (FDA, 2019). 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, although 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).
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