Is there a reason for concern or is it just hype? – A systematic literature review of the clinical consequences of switching from originator biologics to biosimilars

ABSTRACT

Introduction: While prescribing biosimilars to patients naive to a biologic treatment is a well-accepted practice, switching clinically stable patients from an originator to a biosimilar is an issue for clinicians. Well-designed clinical trials and real-world data which study the consequences of switching from an originator biologic treatment to its biosimilar alternative are limited, especially for monoclonal antibodies.

Areas covered: A systematic literature review was conducted on PubMed to identify evidence of the consequences of switching from original biologics to biosimilars. References of included papers were also scrutinized. After a title-, abstract- and full text screening, out of the 153 original hits and 77 additional ones from screening the references, 58 papers (12 empirical papers, 5 systematic reviews and 41 non-empirical papers) were included.

Expert opinion: Preventing patients on biologic medicines from switching to biosimilars due to anticipated risks seems to be disproportional compared to the expected cost savings and/or improved patient access. Indeed, it is the opinion of the authors that the concern of switching to biosimilars is overhyped.

KEYWORDS:

• Biosimilar
• immunogenicity
• patient access
• risk
• societal benefit
• substitution
• switch

Article highlights

• In countries with more limited patient access to biologics, biosimilars can increase the number of patients on biologic medicines without a need for additional resources

• While prescribing a biosimilar drug for patients naive to biologic treatment is a well-accepted option, switching clinically stable patients from an originator product to a biosimilar alternative is a concern for clinicians

• Until the final data are published from ongoing phase 4 clinical trials specifically designed to evaluate the outcomes of switching to biosimilars, a systematic review of relevant publications can provide the most comprehensive evidence

• Altogether, neither systematic reviews, nor empirical papers identified by our review reported that switching from an originator biologic to a biosimilar treatment is associated with an increased risk

• Preventing patients on biologic medicines from switching to biosimilars due to anticipated risks seems to be disproportional compared to the expected cost savings and/or improved patient access as societal benefits

Acknowledgments

Egis Pharmaceuticals PLC had no influence on the review process, nor were they involved in writing the manuscript. The authors summarized their independent professional opinions and take full responsibility for potential errors in the manuscript.

Declaration of interest

Z Kaló is the CEO of Syreon Research Institute while A Inotai and M Csanadi are employees of Syreon Research Institute. Syreon Research Institute has received funding from Egis Pharmaceuticals PLC. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This manuscript was funded by Egis Pharmaceuticals PLC.