Ed: we report below some authoritative works on generics vs. originators, still current, given that the problems they pose have not found solutions and in the light of increasingly frequent withdrawals from the market of drugs that have not followed good production standards.
ORIGINAL DRUGS AND Generic DRUGS: Pharmacological Observations, CLINICAL AND MEDICAL-LEGAL Considerations ABOUT THE PRESCRIPTIVE APPROPRIATENESS
09/2012; University of Palermo; Cannizzaro, Plescia, Cocuzza
SUMMARY In the last ten years the development of the off-patent product market has allowed
significant results from the point of view of containing pharmaceutical expenditure and the overall costs of the National Health Service. However, despite a fundamental saving of public money, some urgent issues, such as substitution, bioequivalence, therapeutic equivalence and post-marketing observations, need to be examined and addressed in order to provide the most detailed information on the use of generic medicines.
Generic drugs are chemically equivalent to their brand-name counterparts in terms of active ingredients, but may differ in marginal features, such as pill color or inert excipients or filler binders, and the specific manufacturing process. Generic drugs must demonstrate that they are “bioequivalent” to their brand name compounds, however this bioequivalence does not clinically equate to therapeutic equivalence. Numerous studies have evaluated the differences in clinical outcomes with generic and brand-name drugs. This could help clinicians pay attention to generic substitutions especially when drugs with narrow therapeutic index are involved.
ORIGINAL DRUGS AND GENERIC DRUGS: PHARMACOLOGICAL, CLINICAL OBSERVATIONS AND MEDICAL-LEGAL CONSIDERATIONS ABOUT THE PRESCRIPTIVE APPROPRIATENESS (full text pdf)
The side effects of the new regulation of prescriptions (Bruno Leoni Institute pdf)
Equivalent drugs (SIF Italian Society of Pharmacology, Position paper)
