Generic and Biosimilar Prescribing in Children and Adolescents: Policy Statement

Guidance from the American Academy of Pediatrics on generic drugs was last published in 1987. The regulatory process for development of a new generic product in place of the reference brand-name drug requires extensive US Food Drug and Administration (FDA) standards for similarity to ensure the same safety and effectiveness profiles as the reference drug. Since the last statement was published, the growth in biologic agents and the development of biosimilars as alternatives to the originator have become more common across the United States. Generic drugs are identical to the brand name drug and must meet the regulatory standard of bioequivalence, whereas biosimilars are "highly similar" but may differ in clinically inactive components and even molecular structure, as long as these differences are not "clinically meaningful." Confidence in the development and approval of generic and biosimilar medications should guide providers toward generic and biosimilar substitution. The recommendations included in this policy statement are intended to support generic substitution and substitutions with interchangeable biosimilars in accordance with the FDA while promoting interdisciplinary interaction between pediatric prescribers and pediatric pharmacists.