National market

Generic pharmaceutical products are drugs with the same pharmaceutical form and qualitative and quantitative composition of medicinal substances as another reference drug, whose efficacy and safety profile has been sufficiently well established by continual clinical use.

Different oral pharmaceutical forms for immediate release can be considered the same pharmaceutical form once bioequivalence has been demonstrated.

The name given to generic pharmaceutical products in Spain is the Denominación Oficial Española (DOE, Spanish equivalent of the international nonproprietary name – INN), or, if none is available, the common or scientific name together with the name or brand of the authorisation holder or manufacturer. Generic pharmaceutical products are identified in Spain by the abbreviation EFG (Especialidad Genérica Española – Spanish generic drug) on the packaging and general labelling.

Generic pharmaceutical products must demonstrate their therapeutic equivalence with the reference products by means of the corresponding bioequivalence studies.

Bioequivalence with the original drug is the technical requirement used to evaluate the clinical safety and efficacy of generic drugs and the one that most concerns doctors, pharmacists and patients. It demonstrates the drug’s therapeutic equivalence with the original, thus guaranteeing their inter-changeability.

The generally accepted concept that “identical plasma concentrations of the same active ingredient produce identical pharmacological effects” means that the comparison of plasma concentrations after the administration of one or other formulation to a given number of subjects is the most suitable instrument for establishing in vivo equivalence or bioequivalence between two products.

Quality requirements for generic pharmaceutical products are exactly the same as for any other pharmaceutical products, as established in EU Commission guidelines on the regulation of medicinal products in the European Union and guidelines on the quality, safety and efficacy of medicinal products for human use. Nowhere do the legislation or technical guidelines for pilot products establish differences that could raise suspicions that these products, whether as raw materials or intermediate and end products, are not manufactured to the same international standards as non-generic drugs. In other words, the lower end price of these drugs is never due to lower quality.

Generic pharmaceutical products have a noticeably lower price than the original products, sometimes as much as 30 %. The reason why the authorisation-holding laboratory can offer the Ministry of Health a lower price is because it does not need to recover basic research costs; thus drugs of the same quality as the originals are obtained at a noticeably lower cost, thereby fulfilling an important social role, by contributing significantly reducing drug costs for the social security system.