Therapeutic Equivalence
- APhA encourages continuing dialogue with other health care organizations on pharmacist's role in therapeutic interchange, including the formation of a task force to include representatives of pharmacy, industry, government, and medicine for the purpose of adoption of uniform terminology and definitions related to chemical, biological, and therapeutic equivalence.
- APhA supports the concept of therapeutic interchange of various drug products by pharmacists based on mutual arrangements between pharmacists and authorized prescribers on behalf of the care of patients.
Biologic, Biosimilar, and Interchangeable Biologic Drug Products
- 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.
Biologic Drug Products
APhA should initiate educational programs for pharmacists and other health care professionals concerning the determination of therapeutic equivalence of generic/biosimilar versions of biologic drug products
Pharmaceutical Alternates
APhA supports recognition of the pharmacist’s role in the selection of pharmaceutical alternates (i.e., drug products containing the same therapeutic moiety, but differing in salt, ester, or comparable physical/chemical form or differing in dosage form)