What is a generic

What’s an equivalent medicine: According to the definition given by the “Legge finanziaria” (Financial Law) in 1996, an equivalent or generic medicine is a “medicine based by one or more active ingredients, industrially produced, not protected by a patent or a complementary protective certification, identified by the active ingredient’s common international definition or, without this definition, by the medicine’s scientific denomination, followed by the AIC owner’s name, that be bioequivalent in respect to a medicinal speciality already authorized with the same quali-quantitative composition in active ingredients, the same pharmaceutical shape and the same therapeutic indications”. The generic medicine’s therapeutic equivalence with the originator is established by the regulatory agencies, based on the guide lines adopted at international level.

Bioequivalence: The Decree D.L. N°219 del 24/04/2006 art.10, 5b defines a Generic Drug as a Drug with the same qualitative and quantitative composition of active principles and the same dosage of the Originator, and in addiction also a Bioequivalence with it proved by Bioavailability studies.

Box 1: Bioavailability: It means the rate and extent to which the active Principle is absorbed from a Pharmaceutical form and becomes available at the general circulation. It can be determined by the AUC (Area Under plasma concentration-time Curve), which is the most accurate measure of Bioavailability.

Companies that produce Generic Drugs have to prove that their product is pharmaceutically equivalent of the originator in effectiveness and safety. Considering that the active principle is the same, The Authority doesn’t request the clinical analysis of the originator but only the Bioequivalence evidence of the Generic. The European guide lines to determine the bioequivalence are defined by the EMEA, the European Agency for the valutation of medicinal products in the document CPMP/EWP/QWP/1401/98.


Box 2: Bioequivalence: Two medicinal products are bioequivalent when their bioavaliability after administration in the same molar dose are similar to such degree that their effects, with respect to both efficency and safety, will be essentially the same.

*(Cfr: Bollettino D’informazione sui Farmaci, anno X N.1-2 2003)

These guide lines constitute the technical and statistics face of bioavailability and are a guarantee of therapeutic equivalence: each generic product has to respect them to obtain the Market Authorization. At Paragraph 3.6.2, EMEA publication explains the statistical method for testing relative bioavailability: The 90% Confidence interval for the measure of relative bioavailability should lie within an acceptance interval of 0.80-1.25. This is wrongly interpreted as a ±20%. This interval depends on variability of the population used for the study.

At last it is important to highlight that also the originator change during the time: when the production or the formulation of the originator changes, it has to pass the same bioequivalence tests of generics to assure that the changing has not produced pharmacokinetics differences.

Law Governing Generics

1996 Legge 425 Generic medicine’s definition Generics’price has to be 20% less than branded, at least 1999 Circolare Min.San. Generics are excluded from the discount on gross ticket sconto sul ticket lordo due to the SSN by the Pharmacist 2001 Legge 405 Reimbursement is the lowest price of generic products Doctor can impose “Not replaceability” Pharmacist informs patient and has to deliver the lowest price drug Price difference has to be paied by the patient 2002 Legge 178 Reimbursement is at the lowest price of the market 2005 Legge 149 Decreto BERSANI Obligation of substitution for C band Discount on OTC and SOP till 20% Definition of Farmaco Equivalente 2006 D.L.219 European Human Code Italian Version 2007 Legge Finanziaria Liberalization of OTC & SOP discount

The market

The Generic pharmaceutical market in Italy is worth about the 3,3% of the total Italian pharmaceutical market, with an IMS value of more than 400 million Euros per year. The annual growth rate of the Generic segment is about the 35% at year. Based on the number of packs sold, the Generic segment represents around 7% of the pharmaceutical market. The size of the Generics segment in Italy is below the level reached in many other European countries: For example, in Germany and in the United Kingdom, the Generics segment represents one pack in three of pharmaceutical products sold. One of the reasons for the comparative underdevelopment of the Generic segment in Italy is due to the longer patent coverage granted to many pharmaceutical products: for example the molecules Omeprazol or Simvastatin, which whilst the rest of Europe have Generic coverage, in Italy these products are still covered by patent. The coming years will be crucial for the development of the Generic sector; a sector that should be significant in reducing public expenditure.