Scientific literature (1993 up to 30 June 2017) was reviewed to identify publications that contained primary data on single or multiple switching from reference biological medicines to biosimilars.

A total of 90 studies were identified involving seven molecular entities that treated 14 disease indications, and enrolled a total of 14,225 individuals.

The great majority of studies did not report differences in safety, efficacy, or immunogenicity after a single switch event compared to patients that were not switched. Only a small number (three) of multiple switch studies have been published to date, but likewise no differences were detected.

Overall, the results suggest a low risk of either a safety concern or a loss of efficacy after switching to a biosimilar.