Italian Medicines Agency Agenzia Italiana del Farmaco

FAQ - Generic medicines

FAQ - Generic medicines

May 2021

What is an equivalent medicine?

Sono definiti “medicinali equivalenti” i medicinali con obbligo di prescrizione medica, aventi uguale composizione in principi attivi, nonché forma farmaceutica, via di somministrazione, modalità di rilascio, numero di unità posologiche e dosi unitarie uguali, ad esclusione di quelli che hanno goduto di coperture brevettale.

It is a medicinal product that contains the same active ingredient in the same amount as a reference medicinal product no longer covered by a patent. These medicines also have the same pharmaceutical form, the same route of administration as the reference medicinal product, in addition to a bioequivalence demonstrated by appropriate bioavailability studies. For the purposes of the definition of a generic  medicine, it should be borne in mind that the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered to be the same active substance if they do not differ significantly in terms of safety and efficacy, and that the various immediate-release oral pharmaceutical forms are considered to be one and the same pharmaceutical form.
From a therapeutic point of view, generic medicines are equivalent to the reference medicinal product and may be used in lieu of it. However, the respective list of excipients reported in the package leaflet needs to be checked in case of subjects with known intolerances.

Generic medicines may have a different composition in terms of excipients and a different appearance in terms of size, colour and shape, in the case of solid oral pharmaceutical forms, compared with the reference medicinal product. In addition, the storage conditions and shelf life of a generic medicine may differ from those of the reference medicinal product. Such differences do not affect the product’s quality, efficacy and safety.
Therapeutic indications may also differ between the reference medicinal product and the generic medicinal product. This may be the case for generic medicinal products approved under the decentralised or mutual recognition procedure, where the indications of the reference medicinal product in the different Member States are not harmonised. In this case, the indications approved for the generic medicine in all Member States will be those of the reference medicinal product authorised in the country acting as the Reference Member State.
Therapeutic indications between reference and generic medicinal products may also differ when certain therapeutic indications authorised for the reference medicinal product are still covered by a patent and cannot be authorised for the generic medicine.

In order to assess the overlap between the generic and the reference medicinal products, studies analysing the bioavailability of the medicine are carried out. Specifically, they measure the speed and amount of active ingredient that enters the bloodstream and that is made available in the body.
If the bioavailability of the generic medicine is comparable, then it can be said that the two medicines are bioequivalent.

Generic medicines are assessed and approved by regulatory authorities (AIFA and other European Competent Authorities or EMA), in accordance with the legislation on medicinal products in force. A dossier should therefore be submitted to the Agency, including bioavailability studies demonstrating the bioequivalence with the reference medicinal product, the results of chemical and pharmaceutical tests demonstrating pharmaceutical equivalence with the reference medicinal product in terms of critical quality attributes, the suitability of the manufacturing process and of the methods used for checking the medicinal product and the stability during its shelf life.
Manufacturers of generic products are not required to carry out safety and efficacy studies again, since these have already been performed by the manufacturer of the reference medicinal product at the time of first approval.

Generic medicines may have a much lower sales price compared with the reference product, up to a maximum reduction of 75%. This is an important resource for citizens and for the National Health Service (NHS). For the former, this generates significant savings on the purchase of NHS reimbursed and non-reimbursed medicines, since the co-payment share equals zero or is reduced. For the latter, it makes it possible to free up resources for purchasing very expensive medicines (such as certain treatments against cancer, AIDS and rare diseases) and to increase — if possible — the offer of free medicines to the general public.

The price of a medicinal product covered by a patent includes not only the manufacturing costs incurred by the company, but also those costs relating to the discovery and synthesis of the new active ingredient, the pharmaceutical development of the medicine and the pre-clinical and clinical studies required by the Regulatory Authority for granting the marketing authorisation. After the patent and the period of market exclusivity have expired, other companies may produce generic medicinal products containing that active ingredient. However, since the latter have not invested in research and development, they may charge a lower selling price than the reference medicinal product.

No, it does not. Generic medicines have quality characteristics that meet the same standards as the reference products. Data certifying the quality of raw materials and the finished product shall be submitted in accordance with the legislation and reference guidelines. The manufacturing sites of generic medicines are regularly inspected by AIFA or other European Competent Authorities and operate in accordance with the Good Manufacturing Practices (GMP). Generic medicinal products are therefore produced according to guaranteed quality standards. It is not the difference in quality that generates the price saving for a generic medicine.

No, even for equivalent medicines there are reimbursement classes: some are paid by the citizen, others reimbursed by the NHS. In cases where several equivalent medicines are marketed containing the same active ingredient, the NHS reimburses the citizen with the amount of the medicine having the lowest price.

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