Low Risk of Safety, Efficacy Concerns After Switching to a Biosimilar

Author(s):

Kelly Davio

In an effort to evaluate whether switching from a reference biologic to a biosimilar could lead to altered clinical outcome, a research team, led by Hillel Cohen, PhD, conducted a systematic literature review of all available switching studies.

This article originally ran on CenterforBiosimilars.com.

Despite the fact that no new safety or efficacy concerns have been detected in more than 10 years and 700 million patient days of experience with biosimilar medicines, some stakeholders remain cautious about switching from reference products to biosimilars, as they fear that such a switch could result in serious problems.

In an effort to evaluate whether switching from a reference biologic to a biosimilar could lead to altered clinical outcomes—such as enhanced immunogenicity, compromised safety, or reduced efficacy—a research team, led by Hillel Cohen, PhD, conducted a systematic literature

review

of all available switching studies.

The researchers searched Medline and Embase databases for switching studies up to June 30, 2017. Publications were considered if they contained efficacy or safety information on a switch from a reference drug to a biosimilar (studies that considered switches from erythropoietin to darbepoetin, erythropoietin to pegylated-erythropoietin, and insulin to insulin were not included).

For more information, please visit CenterforBiosimilars.com.