Biologics and biosimilars are large-molecule therapies made through biotechnology in living systems3
Biologics and biosimilars are not exact chemical copies like generics3,4
Biosimilars are biologic therapies that are highly similar to approved biologics, also known as reference products, and have no clinically meaningful differences in terms of safety and efficacy4
days of patient biosimilar therapy since 2015 as of a September 2023 report5
Estimate: Association Accessible Medicine Report 2023
incremental days of therapy that would not have occurred without biosimilar competition as of a September 2023 report5
Estimate: Association Accessible Medicine Report 2023
approved by the FDA since 2015 as of a February 2025 report6
FDA=US Food and Drug Administration.