Generic medicinal products
Generic (or equivalent) medicines have the same qualitative and quantitative composition in active substances and the same pharmaceutical form as a reference medicine, as well as a bioequivalence with the reference medicine, demonstrated by appropriate bioavailability studies (Article 10, paragraph 5, letter b of Legislative Decree 219/2006).
The term 'generic' medicine has proved to be limiting and misleading as it is perceived by the ordinary citizen as similar but not equal to the reference medicine indicated for the same pathology; for this reason, 'generic' medicines have been redefined as 'equivalent medicines'.
Equivalent medicines must comply with the same quality, efficacy and safety standards and controls as for all authorized medicines: therefore, without prejudice to the doctor's freedom to prescribe, an equivalent medicine can replace the reference medicine (also known as a brand name medicine/originator/branded).
A medicine is equivalent to the reference medicine if bioequivalence studies show that, with the same dose, the concentration profiles in blood versus time are overlapping and therefore it is unlikely that these concentrations will produce relevant differences in terms of efficacy and safety (therapeutic effects/adverse reactions).
Bioequivalence studies are pharmacokinetic studies (from the Greek kinesis, movement, and pharmakon, medicine) whose purpose is to compare the bioavailability of two medicines, i.e. the amount of medicine passing into the bloodstream after administration, in relation to the speed whereby this happens.
Bioequivalence is assessed by comparing the parameters that characterize bioavailability (the maximum plasma concentration of the drug [Cmax]; the time at which this concentration is reached after administration of the drug [Tmax]; the area under the curve [AUC], which represents the trend of the plasma concentration of medicinal products over time).
The ratio of the average concentrations of AUC and Cmax, obtained after administration of the two medicinal products, statistically analyzed, must fall within the acceptable range of 0.80 - 1.25 (or within the range ±20% if using the difference between the parameters rather than their relationship).
The confidence interval (0.80 - 1.25) was conventionally established at an international level taking into account the fluctuations in bioavailability that may occur both in the same subject subjected to the administration of the same medicine at different times, and in different subjects.
After 10 years from the first marketing authorization of the reference medicine (market exclusivity) - period of protection granted to the MAH company to allow it to recover the costs of the investments made in research and development - an equivalent medicine can be marketed at a lower price.
Equivalent medicines are priced at least 20% lower than reference medicines, as a direct consequence of the patent expiry of the active ingredient of the originator medicine. With the expiry of patent protection, the intellectual property rights that a company holds on its active ingredient lapse; it is, in fact, a protection granted to the company to allow it to recover the costs of investments in research and development.
The marketing of an equivalent medicine constitutes a considerable advantage for both the National Health Service (NHS) and the citizen, since the savings achieved can be invested in new innovative medicines for rare or chronic diseases, also considering that more patients will have access to a medicine with the same levels of quality, safety and efficacy.
When equivalent medicines are authorized and classified in class A (i.e. charged to the NHS) they can be included in the AIFA Transparency List, which is updated monthly.
The list contains medicines equal to the reference medicine as regards composition in active ingredients, pharmaceutical form, route of administration, method of release, number of dosage units and unit doses.