Advantages of Sourcing Biosimilars vs. Branded Biologics in Clinical Trials
Summary: When a biologic drug is being studied in a clinical trial, the sponsor may want to compare the investigational product to a current standard of care, known as a comparator drug. In other cases, a co-medication may need to be dosed along with the study drug. Sourcing commercially available branded biologics can be challenging for a variety of reasons, such as high costs and limited or lack of availability. Biosimilars can be used in place of a branded drug (if one exists), offering the sponsor a variety of benefits. But what is a biosimilar, exactly? Can a sponsor just replace the branded drug with the biosimilar, or are there certain requirements that need to be met in order to use it in a clinical trial?