Biosimilar Substitution Laws

This map shows how state laws vary on pharmacists’ ability to autonomously substitute biologics with products called “biosimilars.” Biologics are vaccines and other therapeutic products isolated from human, animal or microorganism tissues and cells, used to treat cancer and other complex diseases. Biosimilars are biological products that are highly similar to a previously approved biologic, as the name implies.

State laws that regulate biosimilar substitution identify criteria that must be met for substitution to occur, require pharmacists to notify prescribers and patients of any substitution, define recordkeeping and labeling requirements, and address pharmacists’ liability for choosing to substitute biosimilars.