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?

Learn more about:

• The formulation comparison between a biosimilar and a branded biologic.
• The cost, availability, and supply chain benefits of using a biosimilar.
• Proactive steps to take that will allow a biosimilar to be used in a clinical trial.

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