Historical Archive


Equivalence is also being discussed among non-designers. Avoid substitutions for antiepileptics, blood products, oral anticoagulants and biological drugs

The usual suspicion continues to hover over "generic" drugs: are they equivalent, in all respects, to the originals? Recently the substitutability between original and generic product has been questioned in particular for antiepileptic drugs, blood products, oral anticoagulants and biological drugs. For example, Professor Giuliano Avanzini of the Besta Institute in Milan is decidedly opposed to the substitutability of antiepileptic drugs: «The aim of antiepileptic drugs is to control seizures; changing the product inevitably changes the pharmacokinetics and therefore the body's response, so the automatic replacement of the prescribed drug could be dangerous». According to Nello Martini, director general of the Italian Medicines Agency (Aifa), responsible for the certification of generics, bioequivalence is instead out of the question: «Pharmaceutical companies that request authorization to market an equivalent present a dossier, which is evaluated on a case-by-case basis, containing data on the purity of the medicinal product and the results of chemical-pharmaceutical tests and clinical trials which certify its bioequivalence, also in terms of bioavailability, a parameter linked to the concentration and residence time of the active ingredient in the blood". «Equivalent, therefore, does not mean identical, just as two different formulations (for example, suppositories and pills) of the same drug from the same manufacturer are not identical – points out Claudio Cricelli, president of the Italian Society of General Medicine. Therefore, the patient's response may not be the same going from the original to the generic, or from one generic to another». "Emphasizing this aspect - specifies Walter Marrocco, family doctor and member of the AIFA Technical-Scientific Commission - does not mean questioning the validity of generics, which the vast majority of us doctors support, but highlighting the delicacy of automatic substitutability ( especially for antiepileptics, blood products and biological drugs) not only between "designer" and generic drugs, but above all from generic to generic. This is because the "deviations" in terms of bioavailability possible between two equivalent generics of the same drug of origin can be wider than the differences between the original drug and each equivalent generic». Hence the request of Mauro Martini, president of the autonomous national union of Italian doctors (Snami), that, if a product, albeit generic, is prescribed with a trade name and company, the pharmacist cannot replace it. «Having a different (albeit equivalent) product every time – says the president of Snami – forces the patient to continuously adapt to the therapy and creates problems of adherence to the treatment. Above all, the elderly follow long-term therapies, often with more medicines a day: changing products can disorient them and increases the risk of error". But Alessandro Carletti, vice president of Federfarma-Milano, follows the Aristotelian consideration that if two generics are equivalent to the same "branded" product, they are also equivalent to each other, followed by another more pragmatic one: «It is impossible for a pharmacy to have stock all the equivalents of each medicine". While acknowledging the problems of pharmacists, Emilio Stefanelli, vice president of Farmindustria, instead breaks a spear in favor of doctors: «Bioequivalence is "statisticians

Articoli correlati

Back to top button
Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco