Switching between Originators and Biosimilars in Dermatology: A Systematic Review of Real-World Clinical Studies

• Published in: Biologics (Basel, Switzerland) Vol. 3; no. 2; pp. 95 - 115
• Main Authors: Nicoletti, Maria Maddalena, Crisci, Erminia, Pentella, Ciro, Cantone, Andrea, Ruggiero, Donatella, Anatriello, Antonietta, Scavone, Cristina
• Format: Journal Article
• Language: English
• Published: Portici MDPI AG 27-04-2023
• Subjects: Biological products; biosimilar; Dermatology; Disease; Etanercept; Infliximab; Marketing; Medical research; Monoclonal antibodies; Nocebos; originator; Psoriasis; Psoriatic arthritis; real-world studies; Safety; Signal transduction; switch; Systematic review; Tumor necrosis factor-TNF; Tumor necrosis factor-α
• ISSN: 2673-8449; 2673-8449
• DOI: 10.3390/biologics3020006

Background. Although biosimilars have been increasingly used over recent years, some concerns about a potential loss of efficacy and altered safety profile when switching from an originator to a biosimilar still exist. Interchangeability can be a challenge for dermatologists too. An extensive systematic review of published switching studies among originators and biosimilars was carried out in order to provide evidence regarding the effects derived from the switch in terms of efficacy and safety outcomes in real-life contexts. Results. Thirty-seven articles were included in this systematic review (14 studies related to adalimumab, 10 to etanercept, 12 to infliximab, and 1 each to adalimumab, etanercept, and infliximab). Studies were mainly carried out among European countries. Most of them were observational studies or register-based studies. The majority of studies enrolled patients diagnosed with psoriasis or psoriatic arthritis who underwent a single switch from the originator to the biosimilar. Overall, the studies’ results demonstrated that switching between adalimumab, etanercept, and infliximab originators and biosimilars is safe and effective in a real-life setting of patients with dermatological conditions. Only a few studies highlighted an increase in the risk of loss of efficacy as well as an increased rate of AEs, both of which were identified as the main causes of biosimilar discontinuation, probably associated with the well-known phenomenon of the nocebo effect. Conclusion. Switching from a biologic originator to its biosimilar is safe and effective. Only a few studies have evaluated the switch among biosimilars; thus, no firm conclusion can be drawn for this type of switch in terms of the efficacy and safety outcomes. Based on our results, we believe that biosimilars can be considered interchangeable with their reference products and that no additional switch studies are necessary to support switching among originators and biosimilars in clinical practice. However, the continuous monitoring of all biologics (both originators and biosimilars) in routine clinical practice is strongly needed given their peculiar safety profile.