Focus on generics
An identical or equivalent medicine?
A generic medicine is one that is either identical or equivalent to a branded version (known as the princeps drug) which no longer enjoys marketing exclusivity since its patent has fallen into the public domain.
Under the terms of the public health code, the generic drug «has the same qualitative and quantitative composition in terms of active ingredient” as the princeps, and “its bioequivalence(1) to the reference princeps has been demonstrated by the appropriate bioavailability(2) studies […]». The active compound in the generic has been in use for many years over a vast panel of patients; it is a reliable drug that treats patients effectively and safely, and it is required by law to be as effective as the original.
Bioequivalence and quality criteria are assessed by the health authorities who grant marketing approval for generics as well as for princeps drugs.
The generic drug may be marketed under its international non-proprietary name (INN), the name of its active compound. In theory, the dosage, indications and contra indications, side effects and safety guarantees are the same as for the princeps. Its sales price, on the other hand, is lower since the manufacturer has no R&D costs to recover.
(1) Bioequivalence: compared bioavailability of the generic drug to the reference product.
(2) Bioavailability: fraction of an administered dose of medication that reaches the systemic circulation.