APhA Policy Manual

Biologic, Biosimilar, and Interchangeable Biologic Drug Products

BIOTECHNOLOGY DRUG CLASSIFICATION DRUG PRICING AND DISTRIBUTION DRUG PRODUCT SELECTION FEDERAL PROGRAMS AND POLICIES RESEARCH

APhA urges the development of laws, regulations, and policies that facilitate patient access to and affordability of biologic products.
APhA urges the Food and Drug Administration (FDA) to expedite the development of standards and pathways that will evaluate the interchangeability of biologic products.
APhA recognizes the Food and Drug Administration’s (FDA) Purple Book as an authoritative reference about biologic product interchangeability within the United States.
APhA opposes interchangeable biologic product substitution processes that require authorization, recordkeeping, or reporting beyond generic product substitution processes.
APhA encourages scientific justification for extrapolation of indications for biologic products to ensure patient safety and optimal therapeutic outcomes.