Biosimilarity and Interchangeability: Principles and Evidence: A Systematic Review.

Area of Science:

• Pharmacology and Therapeutics
• Immunology
• Clinical Pharmacy

Background:

• Concerns exist regarding the efficacy, safety, and immunogenicity of switching between originator biologics and biosimilars, or between different biosimilars.
• Understanding these risks is crucial for clinical decision-making and patient management.

Purpose of the Study:

• To conduct a systematic literature review on the outcomes of switching between biologics and their biosimilars.
• To identify existing evidence gaps concerning biosimilar switching.

Main Methods:

• Systematic literature search across PubMed, EMBASE, and Cochrane Library up to June 2017.
• Inclusion of peer-reviewed studies with efficacy/safety data on switching, excluding those with fewer than 20 switched patients.
• Data extraction focused on interventions, patient populations, switching reasons, efficacy, safety, and anti-drug antibodies.

Main Results:

• Identified 63 publications from 57 switching studies; most switches were non-medical.
• Majority of studies (38/57) involved fewer than 100 patients, with limited long-term follow-up (beyond 1 year in 8/57 studies).
• Most studies reported no statistically significant differences in efficacy or similar safety profiles, but some observed parameter changes.

Conclusions:

• Significant evidence gaps persist regarding the safety of switching between biologics and biosimilars.
• There is a need for adequately powered clinical trials and pharmacovigilance studies with long-term follow-up and multiple switches.
• Further research is essential to support informed decision-making on biosimilar switching.