Which statement is true about interchangeability of generics with brand-name products?

• A. Interchangeability does not require reference products.
• B. Interchangeability is determined only by cost.
• C. A generic must have a Canadian reference product and meet the definition of an interchangeable drug.
• D. Any generic can be considered interchangeable.

Answer: (C)

Interchangeability for generics relies on regulatory evidence that the generic is exactly the same in therapeutic effect as a specific brand-name product. A generic can be substituted only if there is a Canadian reference product to compare to, and the generic has earned the official designation of being interchangeable. That reference product is the brand-name product used as the standard for establishing bioequivalence and therapeutic equivalence. The generic must meet the regulator’s criteria for an interchangeable drug, which goes beyond cost and includes demonstrated bioequivalence and proper labeling, among other requirements. Not every generic automatically qualifies for substitution; only those linked to a Canadian reference product and designated interchangeable are eligible.