Generic or Equivalent Drugs: What They Are, Efficacy and Safety

of active substance does not exceed a certain range of variability considered compatible with the "therapeutic equivalence; this entails an equivalent concentration of active substance at the site of action and, therefore, an equivalent therapeutic effect".

Trying to summarize the concept in a simpler way, two medicines can be considered bioequivalent when the therapeutic equivalence between the two formulations that contain the same active ingredient at the same concentration has been demonstrated.

and that the container and closure system do not interact with the medicine. Holders of sterile medicinal products must submit sterility data demonstrating the microbiological integrity of the products.
  • Of course, both the package leaflet (FI) and the summary of product characteristics (SmPC) of the equivalent medicinal product must be harmonized with those of the reference medicinal product.
  • Excipients

    Unlike what happens for the active ingredients which must be the same in terms of type and dosage, the excipients can be different between equivalent drug and brand name drug.

    The excipients, in fact, are inert substances, not pharmacologically active, the use of which is necessary to make the active principle administrable and to allow stability and shelf life to the pharmaceutical formulation.

    On the other hand, the use of certain excipients could have repercussions in certain categories of patients (think, for example, of allergic phenomena, intolerances, the presence of substances that can interfere with existing pathologies, etc.). Similar aspects, therefore, must be managed through proper training on the package leaflet and on the SmPC of the medicine following the provisions of the European guideline in relation to the paragraph "Special warnings: important information on some of the excipients of the medicine X". This essential information will allow both the doctor and the patient to resort to the use of the equivalent medicine with awareness and tranquility.

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