Switch from Reference Product to Biosimilar “Not Inherently Dangerous”

March 9, 2018

Biosimilars Team

A systematic literature review of 90 studies that involved a switch from a reference biologic to a biosimilar provides reassurance that the act of switching “is not inherently dangerous.” The review was published on March 3, 2018, online ahead of print in the journal Drugs as an open access publication.

The 90 biosimilar switching studies included in the review enrolled 14,225 unique individuals and involved 7 molecular entities used to treat 17 disease indications. In the great majority of studies, there were no reported differences in safety, efficacy, or immunogenicity after a single switch event, compared to patients that were not switched. Likewise, no differences were detected in the three large multiple switch studies that have been published to date. The nature and intensity of safety signals reported after switching from reference products to biosimilars were the same as those already known from continued use of the reference products alone.

The authors conclude that overall, the results suggest a low risk of either a safety concern or a loss of efficacy after switching to a biosimilar. Patients, health care professionals, and the public should not assume that the act of switching from a reference medicine to a biosimilar is problematic.



Cohen HP, Blauvelt A, Rifkin RM, et al. Switching reference medicines to biosimilars: as systematic literature review of clinical outcomes. Drugs. 2018 Mar 3. doi: 10.1007/s40265-018-0881-y. [Epub ahead of print]